Tocilizumab

also known as Actemra · RoActemra · TCZ · MRA · TYENNE · ActemraMR · Actmera · Atlizumab · +8 more

Monoclonal antibody targets IL6, IL6R via inhibition

Developed for: rheumatoid arthritis · COVID-19 · temporal arteritis · pneumonia · plasma cell myeloma · polyarticular juvenile idiopathic arthritis · systemic-onset juvenile idiopathic arthritis · juvenile idiopathic arthritis
+129 more
· acute myeloid leukemia · cytokine release syndrome · disease of orbital part of eye adnexa · major depressive disorder · polymyalgia rheumatica · systemic sclerosis · Takayasu arteritis · hematopoietic and lymphoid cell neoplasm · interstitial lung disease · ischemic stroke · leukemia · relapsing polychondritis · severe acute respiratory syndrome · uveitis · acute chest syndrome · acute respiratory distress syndrome · adamantinous craniopharyngioma · ankylosing spondylitis · Behcet disease · breast cancer · disease related to hematopoietic stem cell transplant · end stage renal failure · generalized myasthenia gravis · graft versus host disease · malignant pancreatic neoplasm · melanoma · metastatic melanoma · multicentric Castleman disease · myelodysplastic syndrome · myocardial infarction · neuromyelitis optica · non-small cell lung carcinoma · schizophrenia · sickle cell disease · viral pneumonia · acute graft versus host disease · acute leukemia · acute respiratory failure · adult-onset Still disease · anterior ischemic optic neuropathy · arthritic joint disease · autoimmune disease · B-cell chronic lymphocytic leukemia · basal cell carcinoma · bone sarcoma · brain ischemia · breast carcinoma · calciphylaxis · carcinoma of urethra · cerebral atherosclerosis · cerebral infarction · cerebral sinovenous thrombosis · chondrocalcinosis · chronic graft versus host disease · chronic leukemia · colitis · cutaneous melanoma · cutaneous neuroendocrine carcinoma · dermatomyositis · diabetic macular edema · disease related to solid organ transplantation · disease related to transplantation · epilepsy · Erdheim-Chester disease · esophageal adenocarcinoma · estrogen-receptor positive breast cancer · familial Mediterranean fever · fever, familial lifelong persistent · fibrous dysplasia · glioblastoma · granulomatosis with polyangiitis · granulomatous mastitis · head and neck cancer · hemophagocytic syndrome · hepatocellular carcinoma · infectious disease with sepsis · inflammatory disease · intermediate uveitis · ischemic disease · liver cancer · lymphoma · myelin oligodendrocyte glycoprotein antibody-associated disease · nasopharyngeal carcinoma · obesity disorder · osteoarthritis, hand · ovarian cancer · pancreatic adenocarcinoma · panuveitis · peritoneal neoplasm · pleural neoplasm · posterior uveitis · prostate adenocarcinoma · pulmonary arterial hypertension · renal pelvis urothelial carcinoma · respiratory tract infectious disorder · rheumatoid arthritis-associated interstitial lung disease · schizoaffective disorder · Schnitzler syndrome · scleroderma · Sjogren syndrome · skin squamous cell carcinoma · soft tissue sarcoma · squamous cell carcinoma · systemic lupus erythematosus · transplant rejection · triple-negative breast carcinoma · type 1 diabetes mellitus · ureter cancer · urinary bladder cancer · urinary bladder carcinoma · urothelial carcinoma · acute myocardial infarction · amyotrophic lateral sclerosis · autoinflammatory syndrome · cardiac arrest · cardiogenic shock · chronic pancreatitis · Cogan syndrome · Cryoglobulinemic vasculitis · cutaneous polyarteritis nodosa · febrile infection-related epilepsy syndrome · HIV infectious disease · immunoglobulin A vasculitis · new-onset refractory status epilepticus · pneumonitis · primary bacterial infectious disease · primary central nervous system vasculitis · respiratory failure · type 2 diabetes mellitus
Investigated by: Hoffmann-La Roche · Chugai Pharmaceutical · Assistance Publique - Hôpitaux de Paris · Genentech, Inc. · National Cancer Institute (NCI) · Roche Pharma AG
+252 more
· Insel Gruppe AG, University Hospital Bern · Massachusetts General Hospital · National Institute of Allergy and Infectious Diseases (NIAID) · Peking Union Medical College Hospital · URC-CIC Paris Descartes Necker Cochin · Capital Medical University · Centre Hospitalier Universitaire Dijon · Herlev Hospital · Medical College of Wisconsin · Oslo University Hospital · Roche Chugai · University of Chicago · Beijing VDJBio Co., LTD. · Brigham and Women's Hospital · Celgene Corporation · Chugai Pharma Taiwan · Columbia University · Emory University · Gilead Sciences · JW Pharmaceutical · M.D. Anderson Cancer Center · Medical University of Vienna · Memorial Sloan Kettering Cancer Center · NYU Langone Health · Nantes University Hospital · National Institutes of Health (NIH) · Norwegian University of Science and Technology · PPD Development, LP · Regeneron Pharmaceuticals · South-Eastern Norway Regional Health Authority · St. Olavs Hospital · Tang-Du Hospital · Tel-Aviv Sourasky Medical Center · Tianjin Medical University General Hospital · University Hospital, Brest · University Hospital, Strasbourg, France · University of Michigan Rogel Cancer Center · University of Nebraska · University of Oslo · University of Southern California · Washington University School of Medicine · Weill Medical College of Cornell University · Abderrahmane Mami Hospital · Abramson Cancer Center at Penn Medicine · Academic Medical Center - University of Amsterdam · Adagene Inc · Affiliated Hospital of Nantong University · Alain Algazi · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · American Head and Neck Society · Amsterdam Rheumatology and Immunology Center · Arcus Biosciences, Inc. · Assaf-Harofeh Medical Center · Assistance Publique Hopitaux De Marseille · Assiut University · Australian and New Zealand Intensive Care Research Centre · Azienda Ospedaliera "Sant'Andrea" · Azienda Ospedaliera Ospedali Riuniti Marche Nord · Azienda Ospedaliero, Universitaria Pisana · Azienda USL Reggio Emilia - IRCCS · Beneficência Portuguesa de São Paulo · Berry Consultants · Bio-Thera Solutions · Biogen · Biogipuzkoa Health Research Institute · Bnai Zion Medical Center · Boston Medical Center · Brazilian Clinical Research Institute · Brazilian Research In Intensive Care Network · Breast Cancer Research Foundation · Brian Miller · Bristol-Myers Squibb · Cedars-Sinai Medical Center · Central People's Hospital of Zhanjiang · all 258 on the full record

Regulatory milestones approvals, filings & regulatory actions · 24 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed adult-onset Still disease 1 milestone
Filed	Japan (PMDA)	ACTEMRA	adult-onset Still disease	2018-05-24	“filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication of adult onset Still's disease” chugai-pharm.co.jp ↗
Filed COVID-19 2 milestones
Filed	US (FDA)	Actemra	COVID-19	2022-04-03	“FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the...” roche.com ↗ “the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental Biologics License Application (sBLA) for Actemra for the treatment of COVID-19 in hospitalized adults” chugai-pharm.co.jp ↗ “FDA has accepted the supplemental Biologics License Application (sBLA) and has granted Priority Review for the humanized anti-human IL-6 receptor monoclonal antibody Actemra” chugai-pharm.co.jp ↗ “FDA has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®” gene.com ↗
Filed	EU (EMA)	Actemra	COVID-19	2021-10-22	“In addition, an application for approval was filed in Europe for Actemra for an additional indication of COVID-19 pneumonia.” chugai-pharm.co.jp ↗
Filed cytokine release syndrome 2 milestones
Filed	Japan (PMDA)	Actemra	cytokine release syndrome	2023-02-28	“announced that it filed regulatory applications with the Ministry of Health, Labour and Welfare for the humanized anti-human IL-6 receptor monoclonal antibody, “Actemra ®” chugai-pharm.co.jp ↗
Filed	Japan (PMDA)	ACTEMRA	cytokine release syndrome	2018-05-28	“filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication of cytokine release syndrome (CRS)” chugai-pharm.co.jp ↗
Filed temporal arteritis 1 milestone
Filed	US (FDA)	Actemra	temporal arteritis	2017-01-23	“FDA has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra® (tocilizumab) for the treatment of GCA” gene.com ↗
Approved Indication not stated 3 milestones
Label expansions (16)	US (FDA)	ACTEMRA	—	2011-01-04 – 2025-08-08	fda.gov ↗
Approved	US (FDA)	ACTEMRA	—	2010-01-08	fda.gov ↗
Approved	EU (EMA)	RoActemra	—	2009-01-16	europa.eu ↗

Trials 333 · started per year

today

EU approved 2009

US approved 2010

20012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 02 trials
Phase 0	NCT03970226	Sep 2019 → May 2024 overdue	adamantinous craniopharyngioma	University of Colorado, Denver	Active not recruiting	No outcome recorded
Phase 0	NCT02447055	Dec 2015 → Jun 2016	plasma cell myeloma	Washington University School of Medicine	Withdrawn	No outcome recorded
Phase 130 trials · 1 met primary
Phase 1	NCT07708038	Sep 2027 → Mar 2030 expected	calciphylaxis	Boston Medical Center	Not yet recruiting	No outcome recorded
Phase 1	NCT07838974	Nov 2026 → Nov 2029 expected	melanoma	University of Southern California	Not yet recruiting	No outcome recorded
Phase 1	NCT07392814	Mar 2026 → Jul 2028 expected	acute myeloid leukemia	Nantes University Hospital	Not yet recruiting	No outcome recorded
Phase 1	NCT06863480	Mar 2026 → Jul 2028 expected	acquired aneurysmal subarachnoid hemorrhage, brain ischemia	University of Florida	Recruiting	No outcome recorded
Phase 1	NCT06016179	Jan 2024 → Jan 2026 overdue	peritoneal neoplasm, pleural neoplasm	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Recruiting	No outcome recorded
Phase 1	NCT06262477	Jan → Sep 2024	—	Biogen	Completed	No outcome recorded
Phase 1	NCT05968508	Aug 2023 → Oct 2024	—	Bio-Thera Solutions	Completed	No outcome recorded
Phase 1	NCT04616248	Jan 2023 → Jan 2027 expected	basal cell carcinoma, bone sarcoma, breast carcinoma, cutaneous neuroendocrine carcinoma +3	University of Southern California	Active not recruiting	No outcome recorded
Phase 1	NCT05391750	Oct 2022 → Feb 2027 expected	plasma cell myeloma	Emory University	Active not recruiting	No outcome recorded
Phase 1	NCT05164133	Jun 2022 → Mar 2024	COVID-19	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT04885829	May 2021 → May 2023	rheumatoid arthritis, temporal arteritis	Syneos Health	Completed	No outcome recorded
Phase 1	NCT04547062	Dec 2020 → Apr 2023	acute myeloid leukemia	Nantes University Hospital	Completed	No outcome recorded
Phase 1	NCT04560205	May → Dec 2020	COVID-19	Lahore General Hospital	Unknown	No outcome recorded
Phase 1	NCT05925140	Mar 2020 → Dec 2024	COVID-19	Lebanese University	Unknown	No outcome recorded
Phase 1	NCT04070781	Jan 2020 → Dec 2021	graft versus host disease	Columbia University	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT03923738	Aug 2019 → Nov 2020	temporal arteritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT03588936	Sep 2018 → Jul 2020	acute leukemia, chronic leukemia, lymphoma, myelodysplastic syndrome	Medical College of Wisconsin	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT03522012	Oct 2017 → Sep 2018	—	Mycenax Biotech Inc.	Completed	No outcome recorded
Phase 1	NCT03135171	Jul 2017 → Mar 2020	breast cancer	University of Michigan Rogel Cancer Center	Completed	No outcome recorded
Phase 1	NCT02336048	Jun 2015 → Sep 2018	B-cell chronic lymphocytic leukemia	Hoffmann-La Roche	Terminated	No outcome recorded
Phase 1	NCT02165345	Jul 2014 → Nov 2021	juvenile idiopathic arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT02057770	Feb 2014 → Jan 2018	acute myeloid leukemia	Washington University School of Medicine	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT01904292	Aug 2013 → Jun 2017	juvenile idiopathic arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT01904279	Jul 2013 → May 2016	polyarticular juvenile idiopathic arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT01455701	Oct 2012 → Jul 2016	systemic-onset juvenile idiopathic arthritis	Hoffmann-La Roche	Completed	Met primary
Phase 1	NCT01696929	Sep 2012 → Dec 2014	schizophrenia	Brian Miller	Completed	No outcome recorded
Phase 1	NCT01418989	Jul → Nov 2011	—	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT01183598	Aug 2006 → Nov 2011	multicentric Castleman disease	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT00046774	Sep 2002 → Jan 2007	systemic lupus erythematosus	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	No outcome recorded
Phase 1	NCT00365001	? → Apr 2008	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded

Phase 1/219 trials · 1 met primary · 3 missed
Phase 1/2	NCT07595900	Jun 2026 → Oct 2028 expected	granulomatous mastitis	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Not yet recruiting	No outcome recorded
Phase 1/2	NCT04691817	Jul 2023 → Dec 2026 expected	non-small cell lung carcinoma	Abramson Cancer Center at Penn Medicine	Recruiting	No outcome recorded
Phase 1/2	NCT04842981	May 2021 → Sep 2022	rheumatoid arthritis	University of Southern Denmark	Terminated	No outcome recorded Stop: Enrollment
Phase 1/2	NCT04524871	Nov 2020 → Jul 2027 expected	liver cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 1/2	NCT03867617	Aug 2019 → Jun 2024 overdue	—	Thomas Wekerle	Active not recruiting	No outcome recorded
Phase 1/2	NCT03869190	Jun 2019 → Oct 2025	urinary bladder cancer, urothelial carcinoma	Hoffmann-La Roche	Completed	Missed primary
Phase 1/2	NCT03745586	Dec 2018 → Nov 2020	temporal arteritis	Insel Gruppe AG, University Hospital Bern	Completed	Missed primary
Phase 1/2	NCT03533101	May 2018 → May 2019	cytokine release syndrome, disease related to hematopoietic stem cell transplant	Hospital Universitario Dr. Jose E. Gonzalez	Completed	No outcome recorded
Phase 1/2	NCT03564340	May 2018 → May 2027 expected	endometrial cancer, fallopian tube cancer, malignant ovarian serous tumor, primary peritoneal carcinoma	Regeneron Pharmaceuticals	Recruiting	No outcome recorded
Phase 1/2	NCT03424005	Mar 2018 → Sep 2030 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 1/2	NCT03193190	Jul 2017 → Feb 2025	pancreatic adenocarcinoma	Hoffmann-La Roche	Completed	Missed primary
Phase 1/2	NCT02997956	Jul 2017 → Jul 2020	hepatocellular carcinoma	University of Michigan Rogel Cancer Center	Withdrawn	No outcome recorded Stop: Business
Phase 1/2	NCT03062579	Feb 2017 → Feb 2018	neuromyelitis optica	Fu-Dong Shi	Completed	No outcome recorded
Phase 1/2	NCT02348216	Apr 2015 → Jul 2023	follicular lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma	Kite, A Gilead Company	Completed	Met primary
Phase 1/2	NCT01603355	Nov 2013 → Feb 2016	juvenile idiopathic arthritis	Eric B. Suhler	Terminated	No outcome recorded Stop: Enrollment
Phase 1/2	NCT01717170	Mar 2013 → Jun 2017	intermediate uveitis, panuveitis, posterior uveitis	University of Nebraska	Unknown	No outcome recorded
Phase 1/2	NCT01594424	Jun 2012 → Nov 2014	end stage renal failure	Cedars-Sinai Medical Center	Completed	No outcome recorded
Phase 1/2	NCT01475162	Aug 2011 → Feb 2016	acute graft versus host disease	Medical College of Wisconsin	Terminated	No outcome recorded
Phase 1/2	NCT01637532	Feb 2011 → Sep 2013	ovarian cancer	Leiden University Medical Center	Completed	No outcome recorded

Phase 290 trials · 4 met primary · 6 missed
Phase 2	NCT03787290	Dec 2026 → Dec 2028	major depressive disorder	Massachusetts General Hospital	Suspended	No outcome recorded
Phase 2	NCT07052058	Jul 2026 → Jul 2028 expected	major depressive disorder	Hospital de Clinicas de Porto Alegre	Not yet recruiting	No outcome recorded
Phase 2	NCT07589634	Jun 2026 → Dec 2027 expected	plasma cell myeloma	Janssen Research & Development, LLC	Recruiting	No outcome recorded
Phase 2	NCT06381661	May 2026 → Jun 2028 expected	infectious disease with sepsis	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT07254637	Apr → Oct 2026 expected	chondrocalcinosis	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT07493317	Mar 2026 → Feb 2031 expected	major depressive disorder	Icahn School of Medicine at Mount Sinai	Recruiting	No outcome recorded
Phase 2	NCT07138898	Dec 2025 → Jan 2028 expected	rheumatic disorder	NYU Langone Health	Recruiting	No outcome recorded
Phase 2	NCT07108387	Dec 2025 → Jun 2027 expected	temporal arteritis	National Institute of Allergy and Infectious Diseases (NIAID)	Recruiting	No outcome recorded
Phase 2	NCT06941376	Nov 2025 → Jul 2027 expected	relapsing polychondritis	University of Pennsylvania	Recruiting	No outcome recorded
Phase 2	NCT07334379	Oct 2025 → Feb 2027 expected	acute respiratory failure	Lorenzo delSorbo	Recruiting	No outcome recorded
Phase 2	NCT05846789	Jul 2024 → Dec 2027 expected	estrogen-receptor positive breast cancer, triple-negative breast carcinoma	Kathy Miller	Recruiting	No outcome recorded
Phase 2	NCT06430736	Jul 2024 → Dec 2026 expected	leukemia, plasma cell myeloma	Insel Gruppe AG, University Hospital Bern	Recruiting	No outcome recorded
Phase 2	NCT06033196	Feb 2024 → Jan 2029 expected	—	National Institute of Allergy and Infectious Diseases (NIAID)	Recruiting	No outcome recorded
Phase 2	NCT05972135	Oct 2023 → Aug 2027 expected	plasma cell myeloma	SCRI Development Innovations, LLC	Recruiting	No outcome recorded
Phase 2	NCT06087731	Sep 2023	disease of orbital part of eye adnexa	Sun Yat-sen University	Withdrawn	No outcome recorded
Phase 2	NCT05874505	Jul 2023 → Nov 2026 expected	uveitis	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT05845723	Jun 2023 → Jun 2026 overdue	Behcet disease	Peking Union Medical College Hospital	Recruiting	No outcome recorded
Phase 2	NCT05640271	Apr 2023 → Dec 2026 expected	acute chest syndrome, sickle cell disease	University of Chicago	Recruiting	No outcome recorded
Phase 2	NCT05233397	Dec 2022 → Dec 2027 expected	adamantinous craniopharyngioma	Nationwide Children's Hospital	Recruiting	No outcome recorded
Phase 2	NCT05067348	Jul 2022 → Dec 2025 overdue	generalized myasthenia gravis	Tang-Du Hospital	Recruiting	No outcome recorded
Phase 2	NCT05957107	May 2022 → Jun 2023	rheumatoid arthritis	Beijing VDJBio Co., LTD.	Completed	No outcome recorded
Phase 2	NCT04729959	Mar 2022 → Jun 2025 overdue	diffuse astrocytoma, glioblastoma	National Cancer Institute (NCI)	Active not recruiting	No outcome recorded
Phase 2	NCT04779957	Oct 2021 → Aug 2024	disease related to transplantation	University Hospital, Toulouse	Completed	No outcome recorded
Phase 2	NCT04940299	Sep 2021 → Dec 2027 expected	carcinoma of urethra, cutaneous melanoma, metastatic melanoma, non-small cell lung carcinoma +3	M.D. Anderson Cancer Center	Active not recruiting	No outcome recorded
Phase 2	NCT05181397	Feb 2021 → Sep 2022	interstitial lung disease	Peking Union Medical College Hospital	Unknown	No outcome recorded
Phase 2	NCT04652258	Feb → Oct 2021	fever, familial lifelong persistent	University of Zurich	Terminated	No outcome recorded
Phase 2	NCT04554771	Jan 2021 → Oct 2022 overdue	esophageal adenocarcinoma	Academic Medical Center - University of Amsterdam	Active not recruiting	No outcome recorded
Phase 2	NCT04688021	Dec 2020 → Dec 2024	graft versus host disease, leukemia	Yi Luo	Unknown	No outcome recorded
Phase 2	NCT03651518	Oct 2020 → Nov 2025	autoimmune disease, inflammatory disease	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT04395222	Oct 2020 → Sep 2022 overdue	hematopoietic and lymphoid cell neoplasm	Weill Medical College of Cornell University	Active not recruiting	No outcome recorded
Phase 2	NCT04375228	Sep 2020 → May 2025 overdue	cancer or benign tumor	Columbia University	Active not recruiting	No outcome recorded
Phase 2	NCT04479358	Sep 2020 → Mar 2024	COVID-19	University of Chicago	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04239196	Sep → Nov 2020	anterior ischemic optic neuropathy, temporal arteritis	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Unknown	No outcome recorded
Phase 2	NCT04564001	Sep 2020 → Feb 2021	Takayasu arteritis	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 2	NCT04476979	Jul 2020 → Jun 2021	COVID-19, respiratory tract infectious disorder, severe acute respiratory syndrome	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT04363853	Jun 2020 → Dec 2026 expected	COVID-19	National Cancer Institute of Mexico	Active not recruiting	No outcome recorded
Phase 2	NCT04370834	May 2020 → Jan 2021	COVID-19, acute respiratory distress syndrome, cancer, hematopoietic and lymphoid cell neoplasm +1	National Cancer Institute (NCI)	Terminated	No outcome recorded
Phase 2	NCT04445272	May → Dec 2020	COVID-19	Fundacion SEIMC-GESIDA	Completed	No outcome recorded
Phase 2	NCT04363736	May → Aug 2020	pneumonia	Hoffmann-La Roche	Completed	No outcome recorded
Phase 2	NCT04435717	May → Nov 2020	COVID-19	Hospital Universitario Ramon y Cajal	Terminated	No outcome recorded
Phase 2	NCT04377659	May 2020 → Oct 2022	COVID-19	Memorial Sloan Kettering Cancer Center	Terminated	No outcome recorded
Phase 2	NCT04377503	May → Aug 2020	COVID-19, cytokine release syndrome	Hospital Sao Domingos	Terminated	No outcome recorded
Phase 2	NCT04335071	Apr → Sep 2020	COVID-19	Insel Gruppe AG, University Hospital Bern	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04321993	Apr 2020 → Apr 2024	COVID-19	Lisa Barrett	Unknown	No outcome recorded
Phase 2	NCT04258150	Apr 2020 → Nov 2021	malignant pancreatic neoplasm	Herlev Hospital	Terminated	Missed primary
Phase 2	NCT04335305	Apr 2020 → Mar 2021	COVID-19, viral pneumonia	MedSIR	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04322773	Apr → Oct 2020	COVID-19	Marius Henriksen	Terminated	No outcome recorded
Phase 2	NCT04331795	Apr → Jun 2020	COVID-19	University of Chicago	Completed	No outcome recorded
Phase 2	NCT04339712	Apr → Dec 2020	COVID-19, macrophage activation syndrome	Hellenic Institute for the Study of Sepsis	Completed	No outcome recorded
Phase 2	NCT04332094	Apr 2020 → Jun 2021	COVID-19	Sant Pau Research Institute	Unknown	No outcome recorded
Phase 2	NCT04346355	Mar → Jun 2020	pneumonia	Azienda USL Reggio Emilia - IRCCS	Terminated	Missed primary
Phase 2	NCT04331808	Mar → May 2020	COVID-19	Assistance Publique - Hôpitaux de Paris	Completed	Mixed
Phase 2	NCT04317092	Mar 2020 → Dec 2023	pneumonia	National Cancer Institute, Naples	Unknown	No outcome recorded
Phase 2	NCT04315480	Mar → Apr 2020	severe acute respiratory syndrome	Marche Polytechnic University	Unknown	No outcome recorded
Phase 2	NCT04876534	Dec 2019 → Dec 2022	disease of orbital part of eye adnexa	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Unknown	No outcome recorded
Phase 2	NCT03821246	Oct 2019 → Apr 2027 expected	prostate adenocarcinoma	David Oh	Recruiting	No outcome recorded
Phase 2	NCT03999749	Jun 2019 → Jul 2023 overdue	melanoma	NYU Langone Health	Active not recruiting	No outcome recorded
Phase 2	NCT03708224	Mar 2019 → Jun 2028 expected	head and neck cancer, squamous cell carcinoma	Alain Algazi	Recruiting	No outcome recorded
Phase 2	NCT03644667	Dec 2018 → Mar 2025	—	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT03699631	Nov 2018 → Mar 2022	hematopoietic and lymphoid cell neoplasm	Medical College of Wisconsin	Completed	No outcome recorded
Phase 2	NCT03554161	May 2018 → Feb 2021	Behcet disease, uveitis	Wenjie Zheng	Terminated	No outcome recorded
Phase 2	NCT03446209	Apr 2018 → Oct 2020	familial Mediterranean fever	University Hospital Tuebingen	Completed	No outcome recorded
Phase 2	NCT03434730	Feb 2018 → Apr 2025	Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome +1	Memorial Sloan Kettering Cancer Center	Completed	Missed primary
Phase 2	NCT03046381	Jul 2017 → Mar 2019	Schnitzler syndrome	Karoline Krause	Completed	No outcome recorded
Phase 2	NCT02929251	Jun 2017 → Oct 2021	uveitis	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 2	NCT03004703	Mar 2017 → Feb 2020	coronary artery disorder, myocardial infarction	Oslo University Hospital	Completed	Met primary
Phase 2	NCT02767557	Jan 2017 → Aug 2021	malignant pancreatic neoplasm	Herlev Hospital	Completed	Missed primary
Phase 2	NCT02511067	Oct 2016	diabetic macular edema	University of Nebraska	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT02660528	Apr 2016 → Jun 2020	major depressive disorder	Brigham and Women's Hospital	Terminated	No outcome recorded
Phase 2	NCT02174263	Feb 2016 → Aug 2019	chronic graft versus host disease	Fred Hutchinson Cancer Center	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT02676947	Jan 2016 → Feb 2018	pulmonary arterial hypertension	Papworth Hospital NHS Foundation Trust	Completed	No outcome recorded
Phase 2	NCT02385110	Sep 2015 → Jan 2023	leukemia	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 2	NCT02293837	Mar 2015 → Jul 2019	type 1 diabetes mellitus	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT02206035	Dec 2014 → Sep 2018	disease related to hematopoietic stem cell transplant	William R. Drobyski, MD	Completed	No outcome recorded
Phase 2	NCT02108600	Jun 2014 → Dec 2018	disease related to solid organ transplantation	Flavio Vincenti	Completed	Met primary
Phase 2	NCT02007239	Dec 2013 → May 2021	hemophagocytic syndrome	Children's Hospital of Philadelphia	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT01910038	Nov 2013 → Dec 2015	temporal arteritis	Centre Hospitalier Universitaire Dijon	Completed	No outcome recorded
Phase 2	NCT01757197	Nov 2013 → Jun 2014	—	Weill Medical College of Cornell University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT01791842	May 2013 → May 2015	fibrous dysplasia	Hospices Civils de Lyon	Completed	No outcome recorded
Phase 2	NCT01727206	Nov 2012 → Feb 2015	Erdheim-Chester disease	Ospedale San Raffaele	Terminated	No outcome recorded
Phase 2	NCT01713842	Jul 2012 → Oct 2014	polymyalgia rheumatica	University Hospital, Brest	Completed	Met primary
Phase 2	NCT01468077	Nov 2011 → Sep 2013	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 2	NCT01441063	Sep 2011 → Jun 2018	multicentric Castleman disease	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 2	NCT01450137	Sep 2011 → Dec 2014	temporal arteritis	Insel Gruppe AG, University Hospital Bern	Completed	Met primary
Phase 2	NCT01491074	Aug 2011 → Nov 2013	myocardial infarction	Oslo University Hospital	Completed	No outcome recorded
Phase 2	NCT01396317	Apr 2011 → Dec 2015	polymyalgia rheumatica	Hospital for Special Surgery, New York	Completed	No outcome recorded
Phase 2	NCT01104480	May → Jul 2010	relapsing polychondritis	McMaster Children's Hospital	Withdrawn	No outcome recorded
Phase 2	NCT01002781	Nov 2009 → Jul 2011	adult-onset Still disease	Tel-Aviv Sourasky Medical Center	Unknown	No outcome recorded
Phase 2	NCT00845832	Mar 2009 → Mar 2013	rheumatoid arthritis	Hoffmann-La Roche	Terminated	No outcome recorded
Phase 2	NCT00144651	Aug 2001 → Jun 2009	rheumatoid arthritis	Chugai Pharmaceutical	Completed	No outcome recorded

Phase 2/38 trials · 3 met primary · 1 missed
Phase 2/3	NCT06452537	Jul 2024 → Jan 2026 overdue	myelin oligodendrocyte glycoprotein antibody-associated disease	Tianjin Medical University General Hospital	Active not recruiting	No outcome recorded
Phase 2/3	NCT06238024	Feb → Jun 2024	ischemic stroke	Suzhou Municipal Hospital of Anhui Province	Completed	Met primary
Phase 2/3	NCT05716035	Apr 2023 → Jul 2024	generalized myasthenia gravis	Tang-Du Hospital	Unknown	No outcome recorded
Phase 2/3	NCT05963048	Dec 2021 → Dec 2022	interstitial lung disease, scleroderma	Assiut University	Completed	No outcome recorded
Phase 2/3	NCT04349410	Apr → Sep 2020	COVID-19	The Camelot Foundation	Completed	No outcome recorded
Phase 2/3	NCT03353259	Nov 2017 → Feb 2021	—	Oslo University Hospital	Terminated	Met primary
Phase 2/3	NCT03350633	Nov 2017 → Sep 2019	neuromyelitis optica	Tianjin Medical University General Hospital	Completed	Met primary
Phase 2/3	NCT01782235	Jul 2013 → Jul 2018	Sjogren syndrome	University Hospital, Strasbourg, France	Completed	Missed primary
Phase 3118 trials · 19 met primary · 12 missed
Phase 3	NCT07335562	Feb 2027 → Nov 2028 expected	systemic sclerosis	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Not yet recruiting	No outcome recorded
Phase 3	NCT07509645	Apr 2026 → Apr 2027 expected	ischemic stroke	Capital Medical University	Recruiting	No outcome recorded
Phase 3	NCT07263776	Dec 2025 → Sep 2026 overdue	ischemic stroke	Capital Medical University	Active not recruiting	No outcome recorded
Phase 3	NCT06447701	Oct → Dec 2025 overdue	cerebral atherosclerosis, cerebral infarction, ischemic disease	Zhujiang Hospital	Not yet recruiting	No outcome recorded
Phase 3	NCT06818266	Aug 2025 → Apr 2027 expected	acute chest syndrome, sickle cell disease	Assistance Publique - Hôpitaux de Paris	Recruiting	No outcome recorded
Phase 3	NCT06297096	Jul 2025 → Dec 2027 expected	interstitial lung disease, systemic sclerosis	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland	Recruiting	No outcome recorded
Phase 3	NCT04871191	Jun 2025 → Oct 2028 expected	granulomatosis with polyangiitis	Assistance Publique - Hôpitaux de Paris	Recruiting	No outcome recorded
Phase 3	NCT06726096	Apr 2025 → Apr 2026 overdue	rheumatoid arthritis	Beijing VDJBio Co., LTD.	Enrolling by invitation	No outcome recorded
Phase 3	NCT06037460	May 2024 → Dec 2027 expected	temporal arteritis	Centre Hospitalier Universitaire Dijon	Active not recruiting	No outcome recorded
Phase 3	NCT05346666	Jun 2022 → Sep 2023	epilepsy	Damanhour University	Unknown	No outcome recorded
Show all 118 trials opens the full record — a long page
Phase 446 trials · 1 met primary · 1 missed
Phase 4	NCT07643038	Sep 2026 → Jul 2029 expected	rheumatoid arthritis-associated interstitial lung disease	Chinese SLE Treatment And Research Group	Not yet recruiting	No outcome recorded
Phase 4	NCT07609940	Jul 2026 → Oct 2027 expected	refractory plasma cell neoplasm	Regeneron Pharmaceuticals	Recruiting	No outcome recorded
Phase 4	NCT07582185	Jun → Sep 2026 overdue	rheumatoid arthritis	Centre Hospitalier Universitaire de Nice	Not yet recruiting	No outcome recorded
Phase 4	NCT06927375	Dec 2024 → Nov 2025 overdue	disease of orbital part of eye adnexa	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Recruiting	No outcome recorded
Phase 4	NCT06251076	Nov 2024 → Jun 2026 overdue	plasma cell myeloma, refractory malignant neoplasm	University Health Network, Toronto	Recruiting	No outcome recorded
Phase 4	NCT06498089	Jun 2024 → Jun 2026 overdue	Takayasu arteritis	Shanghai Zhongshan Hospital	Recruiting	No outcome recorded
Phase 4	NCT05855122	Apr 2023 → Aug 2024	plasma cell myeloma	The First Affiliated Hospital of Soochow University	Unknown	No outcome recorded
Phase 4	NCT05604859	Aug 2022 → Dec 2023	—	Qin Ning	Unknown	No outcome recorded
Phase 4	NCT04762784	Jul 2020 → Feb 2023	—	Peking Union Medical College Hospital	Unknown	No outcome recorded
Phase 4	NCT04730323	May → Jun 2020	COVID-19	FMH College of Medicine and Dentistry	Completed	No outcome recorded
Phase 4	NCT04377750	Apr 2020	pneumonia	Hadassah Medical Organization	Unknown	No outcome recorded
Phase 4	NCT03781310	Dec 2018 → Jun 2019	rheumatoid arthritis	Tel-Aviv Sourasky Medical Center	Unknown	No outcome recorded
Phase 4	NCT03726749	Nov 2018 → Dec 2021	temporal arteritis	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT03301883	Apr 2018 → Sep 2021	systemic-onset juvenile idiopathic arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT03100253	Mar 2018 → Dec 2021	rheumatoid arthritis	Mario Negri Institute for Pharmacological Research	Terminated	No outcome recorded
Phase 4	NCT03227419	Jan 2018 → Sep 2024	rheumatoid arthritis	Lille Catholic University	Unknown	No outcome recorded
Phase 4	NCT03215407	Aug → Dec 2017	rheumatoid arthritis	Chinese PLA General Hospital	Unknown	No outcome recorded
Phase 4	NCT02765074	Jun 2016 → Apr 2025	rheumatoid arthritis	Centre Hospitalier Régional d'Orléans	Completed	No outcome recorded
Phase 4	NCT02659150	May 2016 → Nov 2019	rheumatoid arthritis	Massachusetts General Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02714634	Mar 2016 → Mar 2029 expected	rheumatoid arthritis	University Hospital, Strasbourg, France	Recruiting	No outcome recorded
Phase 4	NCT02573012	Mar 2016 → Feb 2018	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT03244709	Jan 2015 → Dec 2017	temporal arteritis	Hospital of Prato	Unknown	No outcome recorded
Phase 4	NCT01717859	Sep 2014 → Apr 2017	rheumatoid arthritis	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT02087696	May 2014 → Dec 2015	rheumatoid arthritis	Spanish Foundation of Rheumatology	Unknown	No outcome recorded
Phase 4	NCT01991990	May → Dec 2014	—	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT02034474	Feb 2014 → Feb 2017	schizoaffective disorder, schizophrenia	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 4	NCT01734382	Jun 2013 → Oct 2019	juvenile idiopathic arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01878318	Jun 2013 → Jun 2015	rheumatoid arthritis	Hoffmann-La Roche	Withdrawn	No outcome recorded
Phase 4	NCT04157010	May 2013 → Mar 2016	rheumatoid arthritis	University of Leeds	Completed	No outcome recorded
Phase 4	NCT02843789	Mar 2013 → Nov 2017	rheumatoid arthritis	Centre Hospitalier Universitaire de Besancon	Completed	No outcome recorded
Phase 4	NCT01715831	Jan 2013 → Jun 2016	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01602302	Jun 2012 → Nov 2020	rheumatoid arthritis	Medical University of Graz	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01638715	May 2012 → Aug 2018	rheumatoid arthritis	Medical University of Vienna	Completed	No outcome recorded
Phase 4	NCT01251120	Nov 2011 → Jan 2013	rheumatoid arthritis	Hoffmann-La Roche	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01399697	Sep 2011 → May 2014	rheumatoid arthritis	Hoffmann-La Roche	Completed	Missed primary
Phase 4	NCT01331837	Aug 2011 → Mar 2016	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01283971	May 2011 → Aug 2012	rheumatoid arthritis	Hoffmann-La Roche	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01149057	Oct 2010 → Jul 2014	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01163747	Sep 2010 → Dec 2011	rheumatoid arthritis	Genentech, Inc.	Completed	No outcome recorded
Phase 4	NCT01195272	Aug 2010 → Mar 2012	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01119859	May 2010 → Jan 2012	rheumatoid arthritis	Hoffmann-La Roche	Completed	Met primary
Phase 4	NCT01034397	Mar 2010 → Sep 2011	rheumatoid arthritis	Hoffmann-La Roche	Completed	Mixed
Phase 4	NCT02010216	Mar → Jul 2010	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01089023	Jan 2010 → Dec 2011	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT00996203	Oct 2009 → Feb 2011	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT01010503	Jun 2009 → May 2010	rheumatoid arthritis	Hoffmann-La Roche	Completed	No outcome recorded

Phase not applicable19 trials · 1 met primary
—	NCT07377058	Nov 2025 → Oct 2026 expected	dermatomyositis	Peking Union Medical College Hospital	Recruiting	No outcome recorded
—	NCT07491913	Jun 2025 → Dec 2027 expected	Takayasu arteritis	Marmara University	Recruiting	No outcome recorded
—	NCT07801638	Mar 2025 → Sep 2028 expected	cerebral sinovenous thrombosis	Capital Medical University	Recruiting	No outcome recorded
—	NCT07006532	Jan 2025 → Jan 2027 expected	transplant rejection	Shahid Beheshti University of Medical Sciences	Recruiting	No outcome recorded
—	NCT05305066	Feb 2023 → Dec 2028 expected	rheumatoid arthritis	Marie Hudson, MD	Recruiting	No outcome recorded
—	NCT05349149	Apr → Oct 2022	—	Helga Ellingsgaard	Completed	No outcome recorded
—	NCT05082714	Oct 2021 → Jun 2022	COVID-19	University Hospital of Patras	Completed	No outcome recorded
—	NCT06442709	Aug 2021 → Jul 2024	nasopharyngeal carcinoma	Affiliated Hospital of Nantong University	Unknown	No outcome recorded
—	NCT04690920	Jul → Dec 2020	COVID-19	University of Lahore	Completed	No outcome recorded
—	NCT04492501	Apr → Jul 2020	COVID-19, acute respiratory distress syndrome, cytokine release syndrome	UNICEF	Completed	No outcome recorded
—	NCT04519385	Mar → Jul 2020	viral pneumonia	South Valley University	Completed	No outcome recorded
—	NCT03601611	Jan 2019 → Jan 2020	arthritic joint disease, cancer, colitis	Herlev Hospital	Completed	Met primary
—	NCT03507348	Jul 2018 → Nov 2019	end stage renal failure	University Hospital, Grenoble	Terminated	No outcome recorded
—	NCT02901496	Aug 2016 → Apr 2018	obesity disorder	Rigshospitalet, Denmark	Completed	No outcome recorded
—	NCT01245452	May 2010 → Jun 2013	rheumatoid arthritis	Patrick Durez	Completed	No outcome recorded
—	NCT01041248	Jan 2010 → Jan 2012	relapsing polychondritis	Children's Hospital of Eastern Ontario	Completed	No outcome recorded
—	NCT00868751	Mar → Nov 2009	systemic-onset juvenile idiopathic arthritis	Tufts Medical Center	Terminated	No outcome recorded
—	NCT00144560	Feb → Aug 2005	rheumatoid arthritis	Chugai Pharmaceutical	Completed	No outcome recorded
—	NCT00144573	Jan → Oct 2005	rheumatoid arthritis	Chugai Pharmaceutical	Completed	No outcome recorded

Phase not stated1 trial
—	NCT00862758	Feb 2009 → Oct 2010	polyarticular juvenile idiopathic arthritis	University of Oklahoma	No longer available	No outcome recorded
Comparator or background therapy133 trials
Phase 1	NCT07629583 Background	Oct 2026 → Mar 2030 expected	systemic lupus erythematosus	Genentech, Inc.	Recruiting	No outcome recorded
Phase 1	NCT07573332 Background	Sep 2026 → Aug 2030 expected	neuromyelitis optica spectrum disorder with anti-AQP4 antibodies	University of Texas Southwestern Medical Center	Not yet recruiting	No outcome recorded
Phase 1	NCT07594067 Background	Jul 2026 → Jul 2042 expected	cholangiocarcinoma, colorectal cancer, non-small cell lung carcinoma, pancreatic adenocarcinoma	University of Pennsylvania	Recruiting	No outcome recorded
Phase 1	NCT07115745 Background	Sep 2025 → Mar 2029 expected	—	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Recruiting	No outcome recorded
Phase 1	NCT06934044 Background	May 2025 → Nov 2028 expected	plasma cell myeloma	Hoffmann-La Roche	Recruiting	No outcome recorded
Show all 133 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 92

Date	Issuer	Release
2026-06-10	Organon and Co	Regulatory Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19 organon.com ↗ Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE® (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab).
2026-04-29	Gedeon Richter Ltd.	Regulatory Richter receives European Commission approval for Tuyory®, its biosimilar tocilizumab in multiple indications gedeonrichter.com ↗ Gedeon Richter announces today that the European Commission (EC) granted marketing authorization for Tuyory®, its biosimilar to RoActemra® tocilizumab.
2026-02-27	Gedeon Richter Ltd.	Regulatory Richter Receives Positive CHMP Opinion for Marketing Authorisation for Tuyory®, its Biosimilar Tocilizumab in Multiple Indications gedeonrichter.com ↗ Gedeon Richter announces today that it received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending that marketing authorization be granted in Europe for Tuyory®, its proposed biosimilar to RoActemra® tocilizumab.
2025-08-07	Celltrion	Regulatory FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS) celltrion.com ↗ Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years and older with cytokine release syndrome (CRS)
2025-03-27	Gedeon Richter Ltd.	Regulatory Richter Announces Submission to European Medicines Agency for Biosimilar Tocilizumab in Multiple Indications gedeonrichter.com ↗ Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra® tocilizumab – development code: RGB-19.
2025-01-31	Celltrion	Regulatory U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® celltrion.com ↗ Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA®.
2024-12-16	Celltrion	Regulatory Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union celltrion.com ↗ Avtozma, a biosimilar referencing RoActemra® (tocilizumab), has been recommended for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) and giant cell arteritis (GCA).
2024-11-19	Celltrion	Results Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at ACR Convergence 2024 celltrion.com ↗
2024-06-24	Biogen	Regulatory TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®, Approved in the European Union biogen.com ↗ Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCE TM , a biosimilar monoclonal antibody referencing ROACTEMRA ®1 .
2024-06-14	Celltrion	Results Celltrion showcases promising results in phase III study for CT-P47, a biosimilar candidate of RoActemra® (tocilizumab) in patients with rheumatoid arthritis (RA) at EULAR 2024 celltrion.com ↗ Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate, CT-P47, has an equivalent efficacy, and comparable safety and immunogenicity profile to the reference tocilizumab product.
2024-05-23	Janssen Research & Development, LLC	Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗
2024-05-23	Janssen Research & Development, LLC	Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗ Updated analysis with longer-term follow-up from the Phase 1/2 MajesTEC-1 study of TECVAYLI® in patients with relapsed or refractory multiple myeloma receiving prophylactic tocilizumab for the reduction of cytokine release syndrome (Oral Abstract #7517)
2024-04-25	Biogen	Regulatory Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA® biogen.com ↗
2024-03-07	Fresenius Kabi	Regulatory Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA fresenius.com ↗ Fresenius Kabi announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra®* (tocilizumab).
2024-03-07	Fresenius Kabi	Regulatory Fresenius Kabi’s Biosimilar Tyenne® (tocilizumab-aazg) Becomes the First IV and Subcutaneous Tocilizumab Biosimilar Approved by the FDA Tyenne® becomes Fresenius Kabi's first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. fresenius-kabi.com ↗ Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne®* (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra®** (tocilizumab).
2023-09-29	Biogen	Regulatory FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA® biogen.com ↗ Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
2023-09-25	Chugai Pharmaceutical	Regulatory Chugai Obtains Approval for Additional Indication of Actemra for Cytokine Release Syndrome Induced by Cancer Therapy in Japan chugai-pharm.co.jp ↗
2023-09-19	Fresenius Kabi	Regulatory Fresenius Kabi’s biosimilar Tyenne®* becomes first tocilizumab biosimilar approved by the European Commission fresenius.com ↗ The European Commission (EC) has approved Fresenius Kabi’s tocilizumab biosimilar Tyenne ®* .
2023-07-21	Fresenius Kabi	Regulatory Fresenius Kabi’s tocilizumab biosimilar receives positive opinion on Marketing Authorization Application (MAA) for Europe fresenius.com ↗ Fresenius Kabi’s tocilizumab biosimilar candidate, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
2023-07-21	Fresenius Kabi	Regulatory Fresenius Kabi’s Tocilizumab Biosimilar Candidate MSB11456 Receives Positive CHMP Opinion Fresenius Kabi’s tocilizumab biosimilar candidate MSB11456 receives positive CHMP opinion. fresenius-kabi.com ↗ Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the EMA CHMP has adopted a positive opinion recommending the granting of a marketing authorization for its tocilizumab biosimilar candidate MSB11456 referencing RoActemra®* (tocilizumab).
2023-06-05	Janssen Research & Development, LLC	Results Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗ Important new data studying the investigational prophylactic use of tocilizumab (toci), an interleukin-6 receptor inhibitor, for the reduction of CRS in patients treated with TECVAYLI®were also presented at the meeting.
2023-04-24	Chugai Pharmaceutical	Regulatory Chugai’s Actemra Approved in Taiwan for the treatment of COVID-19 in Hospitalized Adults chugai-pharm.co.jp ↗
2023-02-28	Chugai Pharmaceutical	Regulatory Chugai Files for Additional Indication of Actemra for Cytokine Release Syndrome Induced by Cancer Treatment in Japan chugai-pharm.co.jp ↗ We are very pleased to file for regulatory application of Actemra for the additional indication of cytokine release syndrome induced by cancer treatment in Japan,” said Chugai’s President and CEO, Dr. Osamu Okuda.
2022-12-21	Hoffmann-La Roche	Regulatory FDA approves Roche’s Actemra for the treatment of COVID-19 in hospitalised adults roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalised adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
2022-12-21	Genentech, Inc.	Regulatory FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults gene.com ↗ Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.
2022-11-03	Hoffmann-La Roche	Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗ Pre-treatment with Tocilizumab Prior to the CD3 Bispecific Cevostamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Showed a Marked Reduction in Cytokine Release Syndrome Incidence and Severity
2022-11-03	Genentech, Inc.	Results Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs gene.com ↗ Pre-treatment with Tocilizumab Prior to the CD3 Bispecific Cevostamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Showed a Marked Reduction in Cytokine Release Syndrome Incidence and Severity
2022-08-18	Fresenius Kabi	Regulatory Fresenius Kabi’s regulatory submission for tocilizumab biosimilar accepted for review by EMA fresenius.com ↗ The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab).
2022-08-01	Fresenius Kabi	Regulatory Fresenius Kabi’s regulatory submission for tocilizumab biosimilar accepted for review by FDA fresenius.com ↗ The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra®*(tocilizumab).
2022-06-03	Biogen	Results Biogen and Bio-Thera Solutions Present Positive Phase 3 Data for Tocilizumab Biosimilar Candidate at the Annual European Congress of Rheumatology (EULAR 2022) biogen.com ↗ Data from the Phase 3 comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product.
2022-04-04	Hoffmann-La Roche	Regulatory U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
2022-04-04	Chugai Pharmaceutical	Regulatory U.S. FDA Grants Priority Review to Chugai’s Actemra/RoActemra for the Treatment of COVID-19 in Hospitalized Adults chugai-pharm.co.jp ↗ U.S. FDA accepted Genentech’s application for Chugai’s anti-IL-6 receptor antibody Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults, granting priority review
2022-04-03	Genentech, Inc.	Regulatory U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults gene.com ↗ U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
2022-02-11	Hoffmann-La Roche	Regulatory WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19 roche.com ↗ Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Actemra®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification.
2022-01-21	Chugai Pharmaceutical	Regulatory Chugai’s Actemra Approved for Additional Indication of SARS-CoV-2 Pneumonia in Japan chugai-pharm.co.jp ↗
2021-12-13	Chugai Pharmaceutical	Regulatory Chugai Files for Additional Indication of Actemra for COVID-19 Pneumonia in Japan chugai-pharm.co.jp ↗ Application was filed based on the results of several clinical studies in hospitalized patients with COVID-19.
2021-12-08	Chugai Pharmaceutical	Regulatory Chugai’s Actemra/RoActemra Approved by the European Commission to Treat Patients with Severe COVID-19 chugai-pharm.co.jp ↗ We are very pleased that Actemra/RoActemra has been rapidly approved as a new treatment for people with severe COVID-19.
2021-12-07	Hoffmann-La Roche	Regulatory Actemra/RoActemra approved by the European Commission to treat patients with severe COVID-19 roche.com ↗
2021-12-07	Chugai Pharmaceutical	Regulatory CHMP Recommends EU Approval of Chugai’s Actemra/RoActemra to Treat Patients with Severe COVID-19 chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Roche has received notification that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorization for the humanized anti-human IL-6 receptor monoclonal antibody Actemra ® /RoActemra ® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
2021-12-06	Hoffmann-La Roche	Regulatory CHMP recommends EU approval of Actemra/RoActemra to treat patients with severe COVID-19 roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorisation for Actemra®/RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
2021-09-07	Fresenius Kabi	Results Biosimilar candidate of Fresenius Kabi shows positive results in two clinical trials fresenius.com ↗ MSB11456, a tocilizumab biosimilar candidate, successfully met the primary and secondary endpoints in two consecutively conducted clinical trials.
2021-06-25	Hoffmann-La Roche	Regulatory Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
2021-06-25	Chugai Pharmaceutical	Regulatory Genentech Announces FDA Emergency Use Authorization for Chugai’s Actemra for Hospitalized Patients with COVID-19 chugai-pharm.co.jp ↗ Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children
2021-06-24	Genentech, Inc.	Regulatory Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children gene.com ↗ The authorization enables emergency use of Actemra for the treatment of COVID-19 in hospitalized adult and pediatric patients
2021-03-11	Hoffmann-La Roche	Results Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia roche.com ↗ The REMDACTA clinical trial of Actemra/RoActemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone
2021-03-11	Chugai Pharmaceutical	Results Chugai Provides Update on the Phase III REMDACTA Study of Actemra Plus Remdesivir in Patients with Severe COVID-19 Pneumonia chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that the global phase III randomized, double-blind, multicenter REMDACTA study of Actemra ® (tocilizumab) plus remdesivir, versus placebo plus remdesivir, did not meet its primary endpoint.
2021-03-10	Genentech, Inc.	Results Genentech Provides Update on the Phase III REMDACTA Trial of Actemra Plus Veklury in Patients With Severe COVID-19 Pneumonia gene.com ↗ The REMDACTA clinical trial of Actemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone
2021-03-05	Hoffmann-La Roche	Regulatory Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition roche.com ↗ Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease.
2021-03-04	Genentech, Inc.	Regulatory Genentech’s Actemra Becomes the First Biologic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Actemra® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options.
2021-02-10	Gilead Sciences	Results Kite Announces New ZUMA-1 Cohort Analysis Evaluating Prophylactic Corticosteroid Use With Yescarta® in Patients With Relapsed or Refractory Large B-cell lymphoma gilead.com ↗ In the Cohort 6 primary analysis, no Grade ≥3 CRS occurred.
2021-02-09	Chugai Pharmaceutical	Results Results of Phase III Clinical Study in Japan for Actemra in COVID-19 Associated Pneumonia chugai-pharm.co.jp ↗ At 28 day after treatment 35 (72.9%) out of 48 patients treated with Actemra were discharged or became ready to be discharged from the hospital, and 5 (10.4%) experienced fatal outcome.
2020-09-18	Hoffmann-La Roche	Results Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia roche.com ↗ The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.
2020-09-18	Chugai Pharmaceutical	Results Roche Announces Results of EMPACTA Study for Chugai’s Actemra for the Treatment of COVID-19 chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Roche issued a press release today regarding results of EMPACTA study for Actemra ® /RoActemra ® [generic name: tocilizumab (genetical recombination)] for the treatment of COVID-19.
2020-09-17	Genentech, Inc.	Results Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia gene.com ↗ The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.
2020-07-29	Hoffmann-La Roche	Results Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia roche.com ↗
2020-07-29	Chugai Pharmaceutical	Results Chugai Provides an Update on Phase III COVACTA Study of Actemra in Hospitalized Patients with Severe COVID-19 Associated Pneumonia chugai-pharm.co.jp ↗ COVACTA study did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality
2020-07-28	Genentech, Inc.	Results Genentech Provides an Update on the Phase III COVACTA Trial of Actemra in Hospitalized Patients With Severe COVID-19 Associated Pneumonia gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III COVACTA study of Actemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia.
2020-04-08	Chugai Pharmaceutical	Regulatory Chugai Starts Phase III Clinical Trial of Actemra for COVID-19 Pneumonia in Japan chugai-pharm.co.jp ↗ Chugai filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency today to conduct a Phase III clinical trial of Actemra for the treatment of hospitalized patients with severe COVID-19 pneumonia in Japan.
2020-03-24	Chugai Pharmaceutical	Regulatory Genentech Announces FDA approval of Clinical Trial for Chugai’s Actemra for COVID-19 Pneumonia chugai-pharm.co.jp ↗ Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia
2020-03-23	Genentech, Inc.	Regulatory Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia gene.com ↗
2019-05-22	Chugai Pharmaceutical	Regulatory Chugai’s Actemra Intravenous Infusion Receives Additional Approval for Adult Still’s Disease chugai-pharm.co.jp ↗
2019-03-26	Chugai Pharmaceutical	Regulatory Chugai’s Actemra Intravenous Infusion Receives Approval for Additional Indication and Dosing for Cytokine Release Syndrome chugai-pharm.co.jp ↗
2019-03-12	Mycenax Biotech Inc.	Regulatory Mycenax Biotech Inc. announces TGA approval of phase I clinical trial authorization application for LusiNEX to treat aut mycenax.com ↗ Mycenax announced that the of Australian Government Department of Health has approved the phase I application for LusiNEX, Mycenax’s biosimilar product of Actemra®/ RoActemra® being developed to treat autoimmune diseases.
2018-11-26	Genentech, Inc.	Regulatory FDA Approves The ACTpen For Genentech’s ACTEMRA, A Single-Dose, Prefilled Autoinjector For The Treatment Of Rheumatoid Arthritis, Giant Cell Arteritis And Two Forms Of Juvenile Arthritis gene.com ↗ FDA Approves The ACTpen For Genentech’s ACTEMRA, A Single-Dose, Prefilled Autoinjector For The Treatment Of Rheumatoid Arthritis, Giant Cell Arteritis And Two Forms Of Juvenile Arthritis
2018-09-13	Genentech, Inc.	Regulatory FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis gene.com ↗ FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis
2018-05-29	Chugai Pharmaceutical	Regulatory Humanized Anti-Human IL-6 Receptor Monoclonal Antibody “ACTEMRA ® ,” Application for Approval of Additional Indication of Cytokine Release Syndrome Induced by Treatment with CAR-T Cell Therapy chugai-pharm.co.jp ↗ it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication
2018-05-24	Chugai Pharmaceutical	Regulatory Humanized Anti-Human IL-6 Receptor Monoclonal Antibody “ACTEMRA ® ,” Application for Approval of Additional Indication of Adult Onset Still's Disease chugai-pharm.co.jp ↗ announced today that it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication of adult onset Still's disease
2018-05-14	Genentech, Inc.	Regulatory FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis (PJIA), a Rare Form of Juvenile Arthritis gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.
2018-04-17	JW Pharmaceutical	Regulatory [JW중외제약] 악템라 ‘성인 발병성 스틸병’ 급여기준 신설 jw-pharma.co.kr ↗ JW중외제약(대표 전재광·신영섭)은 보건복지부가 고시한 ‘요양급여의 적용기준 및 방법에 관한 세부사항(약제) 고시' 개정안에 따른 Tocilizumab 주사제 ‘악템라주(피하주사162밀리그램)’ 급여기준 신설로 ‘성인 발병성 스틸병’에 대한 건강보험이 적용됐다고 17일 밝혔다.
2017-09-22	Hoffmann-La Roche	Regulatory Roche receives European approval for Actemra /RoActemra in giant cell arteritis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved Actemra®/RoActemra® (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition.
2017-08-30	Hoffmann-La Roche	Regulatory FDA approves Roche’s Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Actemra/RoActemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older.
2017-08-30	Genentech, Inc.	Regulatory FDA Approves Genentech’s Actemra (Tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome gene.com ↗ Actemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy
2017-08-25	Chugai Pharmaceutical	Regulatory Approval of Actemra ® for Additional Indications of Takayasu Arteritis and Giant Cell Arteritis, Both are Designated Intractable Diseases chugai-pharm.co.jp ↗
2017-07-26	Genentech, Inc.	Results Positive Phase III Results of Genentech’s Actemra (Tocilizumab) for the Treatment of Giant Cell Arteritis Published in New England Journal of Medicine gene.com ↗ Fifty-six percent of patients treated with subcutaneous Actemra weekly with a steroid taper phase achieved steroid-free disease remission at one year, versus 14 percent in the placebo plus 26-week steroid taper group
2017-07-21	Hoffmann-La Roche	Regulatory Roche gains positive CHMP opinion for Actemra / RoActemra in giant cell arteritis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra®/RoActemra® (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition.
2017-06-26	Chugai Pharmaceutical	Regulatory Approval of Additional Dosage for “Actemra ® Subcutaneous Injection” Reducing Dose Interval to One Week in Patients with Rheumatoid Arthritis Who Inadequately Respond to Bi-weekly Dose chugai-pharm.co.jp ↗ The dosing interval can be shortened to a minimum of 1 week when sufficient response is not seen.
2017-05-23	Hoffmann-La Roche	Regulatory FDA approves Roche’s Actemra/RoActemra (tocilizumab) for giant cell arteritis roche.com ↗ Actemra/RoActemra is the first therapy approved by the FDA for the treatment of adult patients with GCA.
2017-05-22	Genentech, Inc.	Regulatory FDA Approves Genentech’s Actemra (Tocilizumab) for Giant Cell Arteritis gene.com ↗ Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA.
2017-01-23	Genentech, Inc.	Regulatory FDA Grants Priority Review For Genentech’s Actemra® (Tocilizumab) Supplemental Biologics License Application For Giant Cell Arteritis, a Form of Vasculitis gene.com ↗ The FDA also granted Priority Review Designation for Actemra for the treatment of GCA.
2016-11-30	Chugai Pharmaceutical	Regulatory Filing for Approval of “Actemra ® ” for Additional Indication of “Large Vessel Vasculitis,” the Designated Intractable Disease chugai-pharm.co.jp ↗ it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication of large vessel vasculitis (LVV)
2016-11-12	Hoffmann-La Roche	Results Phase III GiACTA study shows Roche’s Actemra/RoActemra is superior to steroids alone in maintaining steroid-free remission for people with giant cell arteritis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III GiACTA study, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA).
2016-11-12	Genentech, Inc.	Results Phase III GiACTA Study Shows Genentech’s Actemra® is Superior to Steroids Alone in Maintaining Steroid-Free Remission for People with Giant Cell Arteritis gene.com ↗ GiACTA met its primary and key secondary endpoint, demonstrating that Actemra – initially in combination with a six-month steroid (glucocorticoid) taper – enabled significantly more patients to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone.
2016-10-05	Hoffmann-La Roche	Regulatory FDA grants breakthrough therapy designation for Roche’s Actemra/RoActemra in giant cell arteritis, a form of vasculitis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra/RoActemra® (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition.
2016-10-05	Chugai Pharmaceutical	Regulatory Chugai’s ACTEMRA ® /RoACTEMRA ® Receives Breakthrough Therapy Designation from US FDA for Giant Cell Arteritis chugai-pharm.co.jp ↗ TOKYO, October 5, 2016 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ACTEMRA ® /RoACTEMRA ® (tocilizumab), a Chugai originated drug, which is currently under development by Roche and Genentech for the indication of Giant Cell Arteritis (GCA).
2016-10-04	Genentech, Inc.	Regulatory FDA Grants Breakthrough Therapy Designation for Genentech’s Actemra® (Tocilizumab) in Giant Cell Arteritis, a Form of Vasculitis gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra® (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition.
2016-08-25	Chugai Pharmaceutical	Regulatory Application for Approval of Additional Dosage for "Actemra ® Subcutaneous Injection" in Patients with Rheumatoid Arthritis Who Inadequately Respond to Every Other Week Dosage chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has filed an application with the Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional dosage of "Actemra ® Subcutaneous Injection," the humanized antihuman IL-6 receptor monoclonal antibody, in patients with rheumatoid arthritis who inadequately respond to the currently approved every other week dosing regimen.
2016-06-06	Hoffmann-La Roche	Results Phase III study shows Roche's Actemra/RoActemra maintained steroid-free remission in people with Giant Cell Arteritis (GCA) roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase III study known as GiACTA, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA).
2016-06-05	Genentech, Inc.	Results Phase III Study Shows Genentech’s Actemra® (tocilizumab) Maintained Steroid-Free Remission in People with Giant Cell Arteritis (GCA) gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III study known as GiACTA, which evaluated Actemra® (tocilizumab) in people with giant cell arteritis (GCA).
2016-05-16	Chugai Pharmaceutical	Results Efficacy of "Actemra ® Subcutaneous Injection" Confirmed in Dose Interval Reduction Study in Patients with Rheumatoid Arthritis Who Inadequately Respond to Bi-weekly Dose chugai-pharm.co.jp ↗ In terms of the primary endpoint, superiority of weekly dose to bi-weekly dose was confirmed in the MRA231JP study.
2016-03-17	Chugai Pharmaceutical	Regulatory Chugai receives Orphan Drug Designation for Tocilizumab in Systemic Scleroderma chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it received from the Minister of Health, Labour and Welfare, a notification of orphan drug designation for human anti-human IL-6 receptor monoclonal antibody "tocilizumab," a drug under development for treatment of systemic scleroderma.
2015-06-10	Genentech, Inc.	Regulatory FDA Grants Breakthrough Therapy Designation for Actemra (tocilizumab) in Systemic Sclerosis gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra® (tocilizumab) for systemic sclerosis, also known as scleroderma.
2009-06-25	JW Pharmaceutical	Regulatory [JW중외제약] 중외제약, 바이오 오리지널 의약품 “첫 개발” jw-pharma.co.kr ↗ 중외제약(대표 이경하)은 류마티스관절염치료제로 사용되는 바이오 항체치료제 악템라(Actemra)에 대한 3상 임상시험을 식품의약품안전청으로부터 승인 받았다고 17일 밝혔다.

All press releases naming this drug 124 releases

Date	Issuer	Release
Show all 124 releases opens the full record — a long page

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 493 sources stand behind the page.

Field	Value	Cited text
Known as	tocilizumab	“Tocilizumab (Ro-Actemra®) will be administered every 4 weeks at a dose of 8 mg/kg BW (maximum dose of 800 mg); The employed dosage will be calculated using manufacturer...” NCT01638715 ↗ 451 “Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related...” NCT07227597 ↗ “This study compared the pharmacokinetics (PK), safety, and immunogenicity of the Tocilizumab biosimilar, BAT1806 SC (Tocilizumab biosimilar, Subcutaneous Injection), with...” PMID 41069221 ↗ Oct 2025 “This clinical trial is testing a drug called Tocilizumab (a monoclonal antibody) as a first line therapy for subjects with steroid-refractory acute graft versus host disease...” NCT01757197 ↗ “Tocilizumab, an interleukin 6 receptor (IL-6R) antagonist monoclonal antibody, has shown efficacy in patients with coronavirus disease 2019 (COVID-19) pneumonia, but the...” PMID 35024375 ↗ Dec 2021 “Dose tapering of tocilizumab followed by complete treatment discontinuation after a 3-month tapering period in patients with Takayasu arteritis in sustained clinical and...” NCT07491913 ↗ “Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite...” NCT04692493 ↗ “Tocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology.” NCT05002517 ↗ “Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study.” PMID 20112381 ↗ Feb 2010 “Using Tocilizumab, an Humanized Monoclonal Antibody Against the Interleukin - 6 Receptor in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy” NCT04652258 ↗ “Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi).” NCT04322773 ↗ Show 441 more sources
Known as	Actemra	“This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active...” NCT01353859 ↗ 66 “This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with...” NCT01575769 ↗ “This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who...” NCT01667471 ↗ “This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in...” NCT01532869 ↗ “CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to...” NCT05489224 ↗ “In the experimental arm, patients will receive a single standard dose of Tocilizumab (Actemra®) 8 mg/kg b.w. intravenously infused over 1 hour in 250 ml NaCl 0.9%” NCT06430736 ↗ “This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA.” NCT01715831 ↗ “A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers” NCT01418989 ↗ “Subjects will receive 8mg/kg intravenous(IV) ACTEMRA® at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24” NCT06048224 ↗ “Participants will receive Tocilizumab (ACTEMRA®) at 4, 6, or 8 mg/kg IV dose escalation on days 1, 29 and 57.” NCT02997956 ↗ “after administration of Actemra (tocilizumab) in patients who have fever and other cytokine release symptoms” NCT04652258 ↗ Show 56 more sources
Known as	ActemraMR	“The FDA recently approved a randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the safety and efficacy of TCZ (ActemraMR) added to standard care...” NCT04363853 ↗
Known as	Actmera	“study drug anti-IL6R (Tocilizumab (Actmera)) 8 mg/kg given IV during one hour once.” NCT04377750 ↗
Known as	Atlizumab	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05730777 ↗
Known as	humanized anti-IL6 receptor antibody	“humanized anti-IL6 receptor antibody” NCT02101333 ↗
Known as	MRA	“Drug: MRA(Tocilizumab)” NCT00144599 ↗ 12 “MRA (Tocilizumab)” NCT00144508 ↗ “MRA (Tocilizumab)” NCT00144534 ↗ “MRA(Tocilizumab)” NCT00144521 ↗ “MRA(Tocilizumab)” NCT00144547 ↗ “MRA(Tocilizumab)” NCT00144560 ↗ “MRA(Tocilizumab)” NCT00144573 ↗ “MRA(Tocilizumab)” NCT00144586 ↗ “MRA(Tocilizumab)” NCT00144612 ↗ “MRA(Tocilizumab)” NCT00144625 ↗ “MRA(Tocilizumab)” NCT00144651 ↗ Show 2 more sources
Known as	RO4877533	“Tocilizumab (TCZ, RO4877533)” NCT01044498 ↗
Known as	RoAcemtra	“Tocilizumab Infusion RoAcemtra (EU) or Actemra (Rest of the world)” NCT03446209 ↗
Known as	RoActembra	“Tocilizumab (RoActembra). Vials of 20 ml with 400 mg (20mg/ml) and 4ml with 80 mg (20mg/ml).” NCT04363853 ↗
Known as	RoActemra	“Tocilizumab (Ro-Actemra®) will be administered every 4 weeks at a dose of 8 mg/kg BW (maximum dose of 800 mg); The employed dosage will be calculated using manufacturer...” NCT01638715 ↗ 64 “This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active...” NCT01353859 ↗ “This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with...” NCT01575769 ↗ “This study compared the pharmacokinetics (PK), safety, and immunogenicity of the Tocilizumab biosimilar, BAT1806 SC (Tocilizumab biosimilar, Subcutaneous Injection), with...” PMID 41069221 ↗ Oct 2025 “This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who...” NCT01667471 ↗ “This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in...” NCT01532869 ↗ “Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi).” NCT04322773 ↗ “Standard surgery using burr-hole procedure, irrigation and drainage combined with Tranexamic acid (Cyklokapron) and Tocilizumab (RoActemra) administration.” NCT03353259 ↗ “This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA.” NCT01715831 ↗ “A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers” NCT01418989 ↗ “RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy” NCT01587989 ↗ Show 54 more sources
Known as	RoActemra/Actemra	“RoActemra/Actemra (tocilizumab)” NCT02010216 ↗
Known as	TCZ	“This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance...” NCT07108387 ↗ 47 “Patients with rheumatoid arthritis for whom biologics had not failed or who did not discontinue methotrexate because of lack of efficacy or tolerability were followed up for 5...” PMID 27909081 ↗ Dec 2016 “OBJECTIVE: Two randomised controlled trials, AMBITION (NCT00109408) and ADACTA (NCT01119859), showed tocilizumab (TCZ) monotherapy superior to methotrexate (MTX) and adalimumab...” PMID 28955499 ↗ Sep 2017 “The interleukin-6 pathway is up-regulated in giant cell arteritis (GCA), Takayasu arteritis (TA), and polymyalgia rheumatica (PMR). We retrospectively assessed the outcomes of...” PMID 22674883 ↗ Nov 2012 “This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care...” NCT04320615 ↗ “This multicenter, open-label, single arm, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in...” NCT01734993 ↗ “The efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early...” PMID 26511996 ↗ Oct 2015 “Efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were demonstrated in juvenile idiopathic arthritis (JIA) with polyarticular course (pJIA) in the...” PMID 29654485 ↗ Apr 2018 “In this context, the investigators treated 11 patients with refractory chronic inflammatory CPPD with tocilizumab (TCZ), an anti-IL-6 receptor (IL-6R) monoclonal antibody.” NCT07254637 ↗ “Tocilizumab (TCZ) is a humanized recombinant monoclonal antibody of the IgG1 immunoglobulin subclass, is directed against soluble or membrane IL-6 receptors (IL-6R).” NCT04363853 ↗ “Patients were randomized to either TNFi (infliximab, INF), anti-IL-6 (tocilizumab, TCZ), CTLA4-Ig (abatacept, ABA) or anti-CD20 (rituximab, RTX) in addition to MTX.” PMID 34792562 ↗ Jul 2022 Show 37 more sources
Known as	TCZ-SC	“OBJECTIVES: This post hoc analysis of the TOZURA study programme evaluated the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) as monotherapy or with concomitant...” PMID 30649524 ↗ Jun 2019
Known as	Toc	“PURPOSE: This randomized phase-II trial (ClinicalTrials.gov identifier: NCT02767557) compared efficacy of gemcitabine/nab-paclitaxel (Gem/Nab) with or without the...” PMID 40354592 ↗ May 2025
Known as	tocilizumab-aazg	ClinicalTrials.gov intervention name — accepted as the source's own label NCT06863480 ↗
Known as	TYENNE	“tocilizumab-aazg (TYENNE)” NCT06863480 ↗ 1 NCT07570173 ↗
Action	Inhibit	“IL-6 receptor inhibition with tocilizumab” PMID 18625622 ↗ Jul 2008
Modality	Monoclonal antibody	“tocilizumab, an anti-IL-6 receptor monoclonal antibody” PMID 18625622 ↗ Jul 2008
Route	Intravenous	“tocilizumab given intravenously every other week for 12 weeks” PMID 20112381 ↗ Feb 2010
Target	IL6R	“tocilizumab, a humanized monoclonal antibody targeting the interleukin (IL)-6 receptor, recently approved for treating RA.” PMID 22491018 ↗ Apr 2012