Drugs / Cyclosporine
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Cyclosporine

Peptide targets ABCB1, ABCC2, CYP3A4, IL2, TGFB1 via inhibition / activation

Developed for
dry eye syndrome · aplastic anemia · myelodysplastic syndrome · graft versus host disease · leukemia · atopic eczema · disease related to solid organ transplantation · Hodgkins lymphoma
+136 more · lymphoma · psoriasis · chronic hepatitis C virus infection · kidney failure · neutropenia · plasma cell myeloma · transplant rejection · transplant-related bronchiolitis obliterans · vernal keratoconjunctivitis · acute myeloid leukemia · bronchiolitis obliterans syndrome · chronic transplant rejection · COVID-19 · HIV infectious disease · idiopathic membranous glomerulonephritis · leprosy · acquired aplastic anemia · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with t(8;21)(q22;q22) translocation · acute myeloid leukemia, inv(16)(p13.1;q22) · acute myeloid leukemia, t(16;16)(p13.1;q22) · chronic obstructive pulmonary disease · chronic renal failure syndrome · hepatitis C virus infection · immunodeficiency disease · Sjogren syndrome · T-cell large granular lymphocyte leukemia · thrombocytopenia · type 1 diabetes mellitus · acute myocardial infarction · anemia · cardiac arrest · chronic graft versus host disease · chronic kidney disease · cytokine release syndrome · end stage renal failure · eye adnexa disorder · keratitis · leukemia, myeloid, accelerated-phase · lupus nephritis · myocarditis · nephrotic syndrome · pterygium · rheumatoid arthritis · ST-elevation myocardial infarction · type 2 diabetes mellitus · ulcerative colitis · abdominal aortic aneurysm · acute erythroid leukemia · acute graft versus host disease · acute kidney injury · acute megakaryoblastic leukemia in adult · acute myeloblastic leukemia with maturation · acute myeloblastic leukemia without maturation · acute myeloid leukemia with minimal differentiation · acute myeloid leukemia, del(5q31-q32) · acute myelomonocytic leukemia M4 · acute respiratory distress syndrome · adult acute monocytic leukemia · alopecia areata · antisynthetase syndrome · aortic valve disorder · asthenopia · atopic conjunctivitis · atopic keratoconjunctivitis · autoimmune hemolytic anemia · autoimmune hepatitis · autoimmune thrombocytopenia · autosomal recessive disease · benign neoplasm · bone marrow failure syndrome · breast cancer · cardiac valvular defect · cardiovascular disorder · colorectal cancer · colorectal carcinoma · conjunctivitis · corneal disorder · corneal ulcer · cytomegalovirus infection · disease related to transplantation · epiphora due to insufficient drainage · excessive tearing · female breast carcinoma · fungal keratitis · giant cell myocarditis · hemophagocytic syndrome · hypertrophic cardiomyopathy · immunoglobulin A vasculitis · inherited hemoglobinopathy · interstitial cystitis · interstitial lung disease · keratoconjunctivitis · Leber hereditary optic neuropathy · lung disorder · membranous glomerulonephritis · myocardial infarction · open-angle glaucoma · periodontitis · pulmonary fibrosis · purine nucleoside phosphorylase deficiency · refractory plasma cell neoplasm · renal artery obstruction · renal fibrosis · retinitis pigmentosa · retinoblastoma · secondary hemophagocytic lymphohistiocytosis · severe combined immunodeficiency, autosomal recessive, T cell-negative, B cell-negative, NK cell-negative, due to adenosine deaminase deficiency · stenosis of lacrimal punctum · Stevens-Johnson syndrome · sudden cardiac arrest · T-cell leukemia · Tako-tsubo cardiomyopathy · thrombocytopenia due to immune destruction · thrombotic thrombocytopenic purpura · traumatic brain injury · tropical spastic paraparesis · vernal conjunctivitis · alopecia totalis · alopecia universalis · Behcet disease · chronic urticaria · drug rash with eosinophilia and systemic symptoms · epidemic keratoconjunctivitis · focal segmental glomerulosclerosis · glaucoma · heart disorder · hematologic disorder · impaired renal function disease · juvenile dermatomyositis · membranoproliferative glomerulonephritis · primary acquired red cell aplasia · prostate cancer · pure red-cell aplasia · rosacea · uveitis
Investigated by
National Cancer Institute (NCI) · National Heart, Lung, and Blood Institute (NHLBI) · Novartis Pharmaceuticals · Novartis · Allergan · Hoffmann-La Roche
+352 more · Hospices Civils de Lyon · Peking Union Medical College Hospital · Fred Hutchinson Cancer Center · Wyeth is now a wholly owned subsidiary of Pfizer · Sun Pharmaceutical Industries, Inc. · National Institute of Allergy and Infectious Diseases (NIAID) · Novaliq GmbH · University of Oslo School of Pharmacy · Alert Hospital, Ethiopia · Armauer Hansen Research Institute, Ethiopia · Bristol-Myers Squibb · Homes and Hospitals of St Giles · Huons Co., Ltd. · London School of Hygiene and Tropical Medicine · M.D. Anderson Cancer Center · Pfizer · Santen SAS · University of California, San Francisco · Alexandria University · AstraZeneca · Baylor College of Medicine · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Peking University Third Hospital · Sirion Therapeutics, Inc. · University of Alabama at Birmingham · Zambon SpA · Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · APT Pharmaceuticals, Inc. · Alexion Pharmaceuticals, Inc. · Alliance for Clinical Trials in Oncology · Assistance Publique - Hôpitaux de Paris · Assiut University · Astellas Pharma Inc · Beijing Friendship Hospital · Boehringer Ingelheim · Boston Sight · Campus-Bio-Medico University · Celgene Corporation · Chiesi Farmaceutici S.p.A. · Eli Lilly and Company · Farwaniya Hospital · Genzyme, a Sanofi Company · Georgetown University · GlaxoSmithKline · Hanlim Pharm. Co., Ltd. · Harrow Inc · Hospital Universitario Dr. Jose E. Gonzalez · Hospital Universitario Virgen de la Victoria · Innovative Medical · Institute of Hematology & Blood Diseases Hospital, China · Jiangsu HengRui Medicine Co., Ltd. · Linyi People's Hospital · Mayo Clinic · Parexel · Peking University People's Hospital · Perle Bioscience, Inc. · Research Insight LLC · SWOG Cancer Research Network · Taejoon Pharmaceutical Co., Ltd. · The Cleveland Clinic · University Hospital Birmingham · University Hospital, Angers · University Hospital, Limoges · University Medical Center Groningen · University of Aarhus · University of California, Davis · University of Erlangen-Nürnberg Medical School · University of Miami · Yonsei University · 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · AHS Cancer Control Alberta · Achillion, a wholly owned subsidiary of Alexion · Affiliated Hospital of Jining Medical University · Affiliated Hospital of Youjiang University of Ethnic Medicine · all 358 on the full record

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed dry eye syndrome 2 milestones
Filed China (NMPA) — dry eye syndrome 2023-03-21

“SHR8028 (cyclosporine ophthalmic solution) eye drops for the treatment of the signs and symptoms of dry eye disease was accepted by NMPA.” novaliq.com ↗

Filed US (FDA) — dry eye syndrome 2017-12-27

“the US FDA has accepted a New Drug Application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%” sunpharma.com ↗

Filed vernal conjunctivitis 1 milestone
Filed US (FDA) — vernal conjunctivitis 2020-10-26

“The NDA submission for cyclosporine topical ophthalmic emulsion, 0.1% is supported by data from VEKTIS (NCT01751126)” santen.com ↗

Approved Indication not stated 2 milestones
Approved EU (EMA) Ikervis — 2015-03-19 europa.eu ↗
Approved US (FDA) SANDIMMUNE — 1983-11-14 fda.gov ↗

Trials 365 · started per year

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EU approved 2015
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 04 trials
Phase 0 NCT07029204 Aug 2025 → Jul 2026 overdue alopecia areata University of California, Davis Recruiting No outcome recorded
Phase 0 NCT07239128 May 2024 → Jun 2025 dry eye syndrome University of Seville Completed No outcome recorded
Phase 0 NCT04812951 Feb → Jun 2021 — Campus-Bio-Medico University Completed No outcome recorded
Phase 0 NCT00378677 Feb 2007 → ? bronchiolitis obliterans syndrome University Medical Center Groningen Unknown No outcome recorded
Phase 158 trials
Phase 1 NCT07862114 Oct 2026 → Jan 2027 expected digestive system neoplasm GlaxoSmithKline Not yet recruiting No outcome recorded
Phase 1 NCT07774325 Sep → Oct 2026 expected — Boehringer Ingelheim Recruiting No outcome recorded
Phase 1 NCT07565441 May → Nov 2026 expected autosomal dominant polycystic kidney disease Jemincare Not yet recruiting No outcome recorded
Phase 1 NCT07196449 May → Jun 2025 overdue — Seoul National University Bundang Hospital Active not recruiting No outcome recorded
Phase 1 NCT06837259 Mar → Jun 2025 — Pfizer Completed No outcome recorded
Phase 1 NCT06892756 Mar → Jun 2025 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT06809608 Feb → May 2025 — Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT06541678 Dec 2024 → Mar 2025 — Pfizer Completed No outcome recorded
Phase 1 NCT06005714 Aug → Oct 2023 — Shanghai Vinnerna Biosciences Co., Ltd. Completed No outcome recorded
Phase 1 NCT05573230 Oct 2022 → Jan 2023 — Eli Lilly and Company Completed No outcome recorded
Phase 1/216 trials · 3 met primary
Phase 1/2 NCT05794425 Aug 2023 → Apr 2025 bone marrow failure syndrome Shandong Qilu Stem Cells Engineering Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04918823 Jul 2021 → Apr 2023 eye adnexa disorder Boston Sight Completed No outcome recorded
Phase 1/2 NCT04362670 Apr 2020 → Aug 2021 dry eye syndrome Ocular Therapeutix, Inc. Completed No outcome recorded
Phase 1/2 NCT02496975 Aug 2017 traumatic brain injury Edward Hall,PhD Withdrawn No outcome recorded
Phase 1/2 NCT01623167 Jul 2012 → Jan 2018 overdue aplastic anemia National Heart, Lung, and Blood Institute (NHLBI) Active not recruiting Met primary
Phase 1/2 NCT01650545 Jul 2012 → Aug 2015 chronic transplant rejection, disease related to solid organ transplantation, immunodeficiency disease, transplant-related bronchiolitis obliterans University of Maryland, Baltimore Completed Met primary
Phase 1/2 NCT01342887 Apr 2011 → Mar 2012 acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +8 Fred Hutchinson Cancer Center Terminated No outcome recorded
Phase 1/2 NCT01193283 Aug 2010 → Sep 2014 aplastic anemia, neutropenia, pancytopenia National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 1/2 NCT00974142 Sep 2009 → Dec 2016 chronic obstructive pulmonary disease Michael Donahoe Completed No outcome recorded
Phase 1/2 NCT00741338 Sep 2008 → Sep 2012 mucopolysaccharidosis type 1 Genzyme, a Sanofi Company Completed No outcome recorded
Phase 292 trials · 1 met primary · 6 missed
Phase 2 NCT07523009 Jun 2026 → Dec 2028 aplastic anemia Peking Union Medical College Hospital Withdrawn No outcome recorded
Phase 2 NCT07124078 May 2026 → Jan 2029 expected chronic graft versus host disease Incyte Corporation Recruiting No outcome recorded
Phase 2 NCT07558434 Apr 2026 → Dec 2028 expected aplastic anemia Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT07029139 Jun 2025 → Apr 2027 expected idiopathic membranous glomerulonephritis Shanghai JMT-Bio Inc. Not yet recruiting No outcome recorded
Phase 2 NCT07010237 Feb 2025 → Dec 2028 expected aplastic anemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2 NCT05946772 Feb 2025 → Feb 2027 expected Tako-tsubo cardiomyopathy University Hospital Heidelberg Recruiting No outcome recorded
Phase 2 NCT06004752 Aug 2023 → Aug 2024 aplastic anemia Peking Union Medical College Hospital Unknown No outcome recorded
Phase 2 NCT05733624 Jan → Aug 2023 dry eye syndrome SCAI Therapeutics Completed No outcome recorded
Phase 2 NCT05399732 Dec 2022 → Feb 2025 aplastic anemia Bing Han Completed No outcome recorded
Phase 2/39 trials · 1 met primary
Phase 2/3 NCT04637633 Aug → Oct 2020 epiphora due to insufficient drainage Farwaniya Hospital Completed No outcome recorded
Phase 2/3 NCT03292809 Oct 2017 → May 2018 dry eye syndrome Novaliq GmbH Completed No outcome recorded
Phase 2/3 NCT02416388 Jan 2015 → Jul 2025 overdue acute myeloid leukemia University Hospital, Angers Recruiting Met primary
Phase 2/3 NCT00919815 Aug 2010 → Dec 2012 leprosy London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 2/3 NCT00773292 Aug 2006 → Jan 2010 tropical spastic paraparesis Imperial College London Completed No outcome recorded
Phase 2/3 NCT00328653 May 2006 → Feb 2007 vernal conjunctivitis Santen SAS Completed Mixed
Phase 2/3 NCT00403728 Sep 2004 → ? myocardial infarction Hospices Civils de Lyon Unknown No outcome recorded
Phase 2/3 NCT00070187 Nov 2003 → Jun 2005 lymphoma Children's Oncology Group Completed No outcome recorded
Phase 2/3 NCT00003187 May 1995 → Feb 2005 leukemia, lymphoma, myelodysplastic syndrome Virginia Commonwealth University Completed No outcome recorded
Phase 375 trials · 2 met primary · 10 missed
Phase 3 NCT07653581 Jun 2026 → Dec 2028 expected myelodysplastic syndrome Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07522996 Jun 2026 → Dec 2028 aplastic anemia Peking Union Medical College Hospital Withdrawn No outcome recorded
Phase 3 NCT07548671 Apr 2026 → Dec 2028 expected aplastic anemia Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06658002 Sep 2025 → Sep 2027 expected corneal ulcer, fungal keratitis University of California, San Francisco Recruiting No outcome recorded
Phase 3 NCT06766357 Apr 2025 → Feb 2026 overdue dry eye syndrome Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. Recruiting No outcome recorded
Phase 3 NCT06392438 Apr 2024 → Sep 2025 dry eye syndrome University of Sherbrooke Unknown No outcome recorded
Phase 3 NCT05743764 Mar 2023 → Feb 2024 dry eye syndrome Huons Co., Ltd. Completed No outcome recorded
Phase 3 NCT04979884 Jan → Sep 2022 acute respiratory distress syndrome, cytokine release syndrome, pulmonary fibrosis Alexandria University Completed No outcome recorded
Phase 3 NCT05057468 Oct 2021 → Nov 2026 expected autoimmune hemolytic anemia Assiut University Recruiting No outcome recorded
Phase 3 NCT04877288 Jul 2021 → Dec 2032 expected — Bristol-Myers Squibb Recruiting No outcome recorded
Phase 481 trials · 4 met primary
Phase 4 NCT07368595 Sep 2026 → Mar 2027 expected dry eye syndrome Baylor College of Medicine Not yet recruiting No outcome recorded
Phase 4 NCT07352566 Aug 2026 → Jun 2030 expected atopic eczema, psoriasis University of California, San Francisco Not yet recruiting No outcome recorded
Phase 4 NCT07224529 Jun 2026 → Feb 2027 expected — University of Alabama at Birmingham Recruiting No outcome recorded
Phase 4 NCT07553455 Apr → Dec 2026 expected dry eye syndrome Canyon City Eyecare Enrolling by invitation No outcome recorded
Phase 4 NCT07025811 Jul 2025 → Jul 2026 overdue dry eye syndrome Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 4 NCT06424639 May 2024 → May 2025 aplastic anemia Peking Union Medical College Hospital Withdrawn No outcome recorded
Phase 4 NCT04515329 Dec 2023 dry eye syndrome Vishal Jhanji Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT06482177 Oct 2023 → Jun 2024 dry eye syndrome Research Insight LLC Completed No outcome recorded
Phase 4 NCT05867329 Sep 2023 → May 2026 overdue ulcerative colitis Berinstein, Jeffrey Recruiting No outcome recorded
Phase 4 NCT06009497 Aug 2023 → Dec 2024 aplastic anemia Peking Union Medical College Hospital Unknown No outcome recorded
Phase not applicable29 trials · 1 met primary · 1 missed
— NCT07406932 May 2026 → Jul 2027 expected antisynthetase syndrome, interstitial lung disease China-Japan Friendship Hospital Recruiting No outcome recorded
— NCT06898853 Jun 2025 → Dec 2026 expected dry eye syndrome The University of New South Wales Recruiting No outcome recorded
— NCT06981104 Nov 2024 → Feb 2025 asthenopia, dry eye syndrome Second Affiliated Hospital, School of Medicine, Zhejiang University Completed No outcome recorded
— NCT07171710 Mar 2024 → Mar 2026 overdue dry eye syndrome Tianjin Eye Hospital Enrolling by invitation No outcome recorded
— NCT06147375 Dec 2023 → Dec 2026 expected — Wei Gao Not yet recruiting No outcome recorded
— NCT05957211 May 2023 → Feb 2024 dry eye syndrome University of Waterloo Completed No outcome recorded
— NCT05782933 Aug 2022 → Dec 2023 idiopathic membranous glomerulonephritis Beijing Friendship Hospital Unknown No outcome recorded
— NCT05131152 Dec 2021 → Jul 2023 dry eye syndrome Zhongshan Ophthalmic Center, Sun Yat-sen University Unknown No outcome recorded
— NCT05771012 Jan 2021 → Oct 2022 stenosis of lacrimal punctum Farwaniya Hospital Completed No outcome recorded
— NCT04705584 Jan → Oct 2021 vernal keratoconjunctivitis Assiut University Unknown No outcome recorded
Phase not stated1 trial
— NCT00633373 — transplant-related bronchiolitis obliterans APT Pharmaceuticals, Inc. No longer available No outcome recorded
Comparator or background therapy481 trials
Phase 0 NCT06949267 Background Jun 2025 → Sep 2026 overdue acute graft versus host disease Ruijin Hospital Not yet recruiting No outcome recorded
Phase 0 NCT04988256 Comparator Sep 2021 → Apr 2026 overdue drug rash with eosinophilia and systemic symptoms University of Southern California Enrolling by invitation No outcome recorded
Phase 0 NCT02653196 Background Sep 2015 → Aug 2017 neuroepithelial neoplasm Montefiore Medical Center Terminated No outcome recorded
Phase 0 NCT02181478 Background Jul 2015 → Dec 2019 B-cell chronic lymphocytic leukemia, Hodgkins lymphoma, acute myeloid leukemia, chronic myeloid leukemia +2 Case Comprehensive Cancer Center Completed No outcome recorded
Phase 0 NCT01380535 Background Nov 2011 → Mar 2015 chronic graft versus host disease Mallinckrodt Completed Missed primary
Show all 481 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 36

DateIssuerRelease
2026-06-30 Novaliq GmbH Regulatory Hengrui’s Heng Yi ® Approved in China as an Innovative Cyclosporine Ophthalmic Solution for the Treatment of Dry Eye Disease novaliq.com ↗
Heng Yi ® is the first and only water-free 0.1% cyclosporine ophthalmic solution and the second dry eye disease drug product approved in China based on the EyeSol ® platform technology, following the approval of Heng Qin ® (perfluorohexyloctane ophthalmic solution) in 2025.
2025-12-01 Impax Laboratories, LLC Regulatory Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05% amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials.
2025-08-27 Théa Open Innovation, France Regulatory Théa & Novaliq Launch Vevizye® thea.com ↗
Vevizye® is based on Novaliq’s proprietary EyeSol® technology and the only water-free ciclosporin 0.1% eye drops solution and is approved in the European Union for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients which has not improved despite treatment with tear substitutes.
2024-07-29 Novaliq GmbH Regulatory Novaliq Receives Positive CHMP Opinion FOR Vevizye ® in Dry EYE Disease novaliq.com ↗
The positive opinion is based on the CHMP review of the comprehensive data package from more than 1.500 patients with moderate to severe DED.
2024-07-05 Saptalis Pharmaceuticals LLC Regulatory Saptalis Pharmaceuticals Receives FDA Approval for Cyclosporine Ophthalmic Emulsion, 0.05% saptalis.com ↗
Saptalis Pharmaceuticals, LLC is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion, 0.05%.
2024-06-05 Harrow Inc Results Harrow Announces 52-Week Data from VEVYE® ESSENCE-2 Open-Label Extension Study harrow.com ↗
2023-10-12 Sun Pharmaceutical Industries, Inc. Results CEQUA® (cyclosporine ophthalmic solution) 0.09% Phase 4 Data Showed Sustained Improvement in Dry Eye Disease Signs and Symptoms in Patients Switched From Restasis® (cyclosporine ophthalmic emulsion) 0.05% sunpharma.com ↗
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced the presentation of Phase 4 data showing that CEQUA® (cyclosporine ophthalmic solution) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED).
2023-08-24 Novaliq GmbH Regulatory European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol ® (Ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease novaliq.com ↗
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review.
2023-06-08 Novaliq GmbH Regulatory Novaliq Announces FDA Approval of VEVYE ™ (Cyclosporine Ophthalmic Solution) 0.1%, for the Treatment of the Signs and Symptoms of Dry Eye Disease novaliq.com ↗
2023-04-12 Novaliq GmbH Results Novaliq announces publication of second pivotal phase 3 trial data on CyclASol ® 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology novaliq.com ↗
In ESSENCE-2, 71.6% of CyclASol ® treated patients showed such a response after 4 weeks of treatment, significantly more than in the vehicle group.
2023-03-21 Novaliq GmbH Regulatory Marketing Authorization Application for Dry Eye Disease Drug SHR8028 (Cyclosporine Ophthalmic Solution) developed by Jiangsu Hengrui Pharmaceutical has been accepted in the People’s Republic of China novaliq.com ↗
The marketing authorization application for SHR8028 (cyclosporine ophthalmic solution) eye drops for the treatment of the signs and symptoms of dry eye disease was accepted by NMPA.
2022-10-24 Novaliq GmbH Regulatory Novaliq announces FDA acceptance of the new drug application for CyclASol ® for the treatment of dry eye disease novaliq.com ↗
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol ® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol ® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).

All press releases naming this drug 60 releases

DateIssuerRelease

Evidence & citations 69 cited values

Every value below carries the sentence it was read from. 888 sources stand behind the page.

FieldValueCited text
Known as Cyclosporine “A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE®...” NCT01692834 ↗
615

“Aplastic anemia can be treated effectively with allogeneic bone marrow transplantation and immunosuppressive therapy with horse anti-thymocyte globulin (h-ATG) and cyclosporine...” NCT03413306 ↗

“To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with...” NCT01601821 ↗

“Healthy adult subjects will receive an IV dose of SyB V-1901 alone, simultaneous administration of SyB V-1901 with cyclosporine, and coadministration of cyclosporine at 2 hours...” NCT04542252 ↗

“Oral calcineurin inhibitors (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses) administered in combination with standard...” NCT07406932 ↗

“The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface...” NCT06624384 ↗

“Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target...” NCT00706680 ↗

“Topical Cyclosporine 0.05% (Restasis®) is an anti-inflammatory drug which is the most recommended treatment option for patients with moderate-severe DES who failed conservative...” NCT03403023 ↗

“When a donor organ becomes available for transplant, the patient will receive three anti-rejection drugs-cyclosporine, mycophenolate mofetil and prednisone-to prevent organ rejection.” NCT00009009 ↗

“This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine).” NCT00048152 ↗

“This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease.” NCT05733624 ↗

Show 605 more sources

Known as aurosporine (cyclosporine 2%) “aurosporine (cyclosporine 2%)” NCT02206789 ↗
Known as CEQUA “CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.” NCT04835623 ↗
Known as CequaTM “CequaTM (Cyclosporine 0.09%) ophthalmic solution” NCT04357795 ↗
Known as CicloMulsion (ready-to-use lipid emulsion of Cyclosporine A) “CicloMulsion® (ready-to-use lipid emulsion of Cyclosporine A)” NCT01692834 ↗
Known as ciclosporin “Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive...” NCT02885610 ↗
43

“A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate...” NCT01033305 ↗

“prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis: a randomised trial” PMID 26645190 ↗ Nov 2015

“Intravenous bolus of NeuroSTAT (Ciclosporin) 2.5 mg/kg bodyweight followed by 5 days of 5 mg/kg bodyweight/day continuous infusion” NCT01825044 ↗

“Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)” NCT00919815 ↗

“3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)” NCT04144413 ↗

“Ciclosporin (CSA) 5mg/kg/day orally from day +1 for a minimum of 6 months” NCT01530555 ↗

“Effect of Ciclosporin Eyedrops on Sjögren Syndrome” NCT04597762 ↗

“IKERVIS® (1mg/mL ciclosporin) eye drops” NCT04492878 ↗

“Ciclosporin (e.g. Immunosporin®)” NCT02779114 ↗

NCT02397213 ↗

Show 33 more sources

Known as ciclosporin A “The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical...” NCT06348602 ↗
9

“MATERIALS AND METHODS: Open label, proof of concept, pilot study of 48 weeks therapy with the calcineurin antagonist, ciclosporin A (CsA), in seven patients with 'early' (<two...” PMID 22720101 ↗ Jun 2012

“guideline recommended ciclosporin A (CsA) + anti-thymocyte immunoglobulin (ATG) + thrombopoietin receptor agonists (TPO-RA) as the first-line therapy.” NCT05996393 ↗

“Ciclosporin A (CsA) plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal” NCT01002339 ↗

“ciclosporin A (CsA)+methotrexate (MTX) +mycophenolate Mofetil(MMF)” NCT04203108 ↗

“using once-daily ciclosporin A (CsA) 0.1% cationic emulsion (CE).” PMID 42283972 ↗ Jun 2026

NCT06898853 ↗

NCT00148746 ↗

NCT03689465 ↗

NCT03382301 ↗

Known as Ciclosporin, CsA “Ciclosporin, CsA” NCT02617667 ↗
Known as Ciclosporine (CSA) “Ciclosporine (CSA)” NCT04523129 ↗
Known as Ciclosporine A ClinicalTrials.gov intervention name — accepted as the source's own label NCT00456235 ↗
2

NCT00445081 ↗

NCT00403728 ↗

Known as CIS “The nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then breathed in through a mouthpiece.” NCT01287078 ↗
3

“Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer.” NCT00633373 ↗

“Cyclosporine Inhalation Solution (CIS)” NCT00938236 ↗

“Cyclosporine Inhalation Solution (CIS)” NCT00755781 ↗

Known as CPS “A PHASE I/II STUDY OF RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH METHOTREXATE (MTX) AND CYCLOSPORINE (CPS)” NCT00002790 ↗
Known as CSA “The aim of this study was to compare the long-term safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) plus mycophenolate mofetil (MMF) or...” PMID 19744223 ↗ Sep 2009
112

“MATERIALS AND METHODS: Open label, proof of concept, pilot study of 48 weeks therapy with the calcineurin antagonist, ciclosporin A (CsA), in seven patients with 'early' (<two...” PMID 22720101 ↗ Jun 2012

“Clinical trials have shown that approximately 75-80% of patients who are treated with immunosuppressive drugs, especially the combination of antithymocyte globulin (ATG) and...” NCT00005935 ↗

“Aplastic anemia can be treated effectively with allogeneic bone marrow transplantation and immunosuppressive therapy with horse anti-thymocyte globulin (h-ATG) and cyclosporine...” NCT03413306 ↗

“We conducted a single-arm, phase 2 clinical trial that investigated the addition of tocilizumab, an interleukin-6 receptor blocker, to cyclosporine-A (CSA) and mycophenolate...” PMID 40423982 ↗ May 2025

“Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1%...” NCT00328653 ↗

“To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with...” NCT01601821 ↗

“Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either...” NCT06658002 ↗

“different immunosuppressive regimens (cyclosporine A [CsA]/MMF, Tacr/MMF, Tacr/MMF with conversion to Tacr/Everolimus [ERL]) or by cytokine promoter gene polymorphisms may...” NCT00160966 ↗

“Patients who were newly diagnosed with non-transfusion-dependent non-severe AA (NTD-NSAA) were randomly assigned to receive either cyclosporine (CsA) combined with luspatercept...” PMID 42057135 ↗ Apr 2026

“A total of 50 participants were randomly assigned to either the CsA group (n = 25, cyclosporine A twice a day and hyaluronic acid twice daily) or the control group (n = 25,...” NCT06936462 ↗

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Known as CsA (Cyclosporin) “CsA (Cyclosporin)” NCT00001880 ↗
Known as CsA-CE “PURPOSE: This study evaluates the efficacy and tolerability of cyclosporine A cationic emulsion (CsA-CE) in patients ≥4 years of age with moderate-to-severe vernal...” PMID 37872059 ↗ Oct 2023
Known as CSP “This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and traumatic brain injury (TBI).” NCT02496975 ↗
2

“cyclosporine (CSP) and mycophenolate mofetil (MMF)” NCT01251575 ↗

“cyclosporine (CSP) at initial dose of 6.25 mg/kg” NCT00325741 ↗

Known as CyA “This study aims to investigate the efficacy and safety of low-dose cyclosporine A (CyA) in patients with primary Sjögren's syndrome (pSS) and articular involvement.” PMID 27470087 ↗ Jul 2016
2

“The aim of our study is to compare cyclosporine A (CyA) and methylprednisolone pulses (MP) in the treatment of severe HSN.” PMID 21626222 ↗ May 2011

“Cyclosporine arm (CyA group) consisted of oral cyclosporine A (CyA) 4-5mg/kg/day” NCT00976300 ↗

Known as CyclASol “PURPOSE: To compare the efficacy, safety, and tolerability of waterfree cyclosporine formulation (CyclASol) at 2 concentrations (0.1% and 0.05% of cyclosporine [CsA]) to...” PMID 30703441 ↗ Jan 2019
1

“OBJECTIVE: To assess efficacy, safety, and tolerability of a water-free cyclosporine ophthalmic solution, 0.1% (CyclASol [Novaliq GmbH]), applied twice daily in DED compared...” PMID 37022717 ↗ May 2023

Known as cyclo “Although high doses of cyclosporin (cyclo) inhibits the development of type 1 diabetes mellitus” NCT00905073 ↗
Known as Cyclosporin “cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days)” NCT02834468 ↗
44

“MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol” NCT00764725 ↗

“Cyclosporin will begin on day -2 (IV or oral) for at least 180 days.” NCT01015742 ↗

“Cyclosporin is administered at a dose of 3-5mg/kg per day.” NCT06254560 ↗

“Tacrolimus, Cyclosporin, NeoOral, Prograf” NCT01455649 ↗

“Cyclosporin for inhalation twice daily” NCT01334892 ↗

“Restasis (topical cyclosporin)” NCT00348335 ↗

“topical cyclosporin eyedrops” NCT04597762 ↗

“0.05% cyclosporin eye drop” NCT00705510 ↗

“Drug: Cyclosporin (CSA)” NCT07375654 ↗

NCT00200551 ↗

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Known as Cyclosporin 0.05% emulsion (Restasis) “Cyclosporin 0.05% emulsion (Restasis)” NCT02199964 ↗
Known as cyclosporin A “This study compares the long-term efficacy and safety of interferon (IFN) α2a and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral...” NCT03209219 ↗
9

“This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) and cyclosporin a (CSA) on idiopathic inflammatory myopathy (IIM)” NCT04237987 ↗

“Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion binds to cyclophilin D and blocks the opening of mPTP after reperfusion.” NCT02876250 ↗

“The Effects of Cyclosporin A Emulsion, (Restasis), on the Ocular Surface in Response to Low Humidity Environment in Patients With Dry Eye” NCT02199964 ↗

“Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the expression of the interleukin-2 receptor.” NCT00987467 ↗

“These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion.” NCT01901471 ↗

“cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes.” NCT07171710 ↗

“sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A” NCT00764725 ↗

“Cyclosporin A 1.5 mg/kg/day iv from -2, then 3 mg/kg/day iv” NCT01087398 ↗

“Cyclosporin A (Sandimmun Neoral® or similar):” NCT02936505 ↗

Known as Cyclosporin: NEORAL “Cyclosporin: NEORAL” NCT00922129 ↗
Known as cyclosporine (Neoral, Sandimmune and other trade names) “cyclosporine (Neoral, Sandimmune and other trade names)” NCT00132691 ↗
Known as Cyclosporine A “A Non-randomized, Phase II Study of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A (ATG/CsA) in Subjects With Moderate or More Severe Aplastic...” NCT02404025 ↗
142

“The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate,...” NCT03320642 ↗

“We conducted a single-arm, phase 2 clinical trial that investigated the addition of tocilizumab, an interleukin-6 receptor blocker, to cyclosporine-A (CSA) and mycophenolate...” PMID 40423982 ↗ May 2025

“Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1%...” NCT00328653 ↗

“This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant...” NCT01650545 ↗

“different immunosuppressive regimens (cyclosporine A [CsA]/MMF, Tacr/MMF, Tacr/MMF with conversion to Tacr/Everolimus [ERL]) or by cytokine promoter gene polymorphisms may...” NCT00160966 ↗

“Purpose: To compare the efficacy and ocular tolerability of a 0.08% nanoemulsion cyclosporine A (CsA) (TJO-087) once daily versus a conventional 0.05% emulsion CsA twice daily...” PMID 36450107 ↗ Nov 2022

“The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with...” PMID 25083776 ↗ Sep 2014

“The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in...” NCT06348602 ↗

“Cyclosporine A is a calcineurin inhibitor, which has an effect on reducing T-cell proliferation and activation, can reverse pancytopenia and alleviate transfusion requirements in NSAA.” NCT05660785 ↗

“OBJECTIVE: To assess patients' experiences with topical cyclosporine A (tCSA) 0.05% ophthalmic emulsion (Restasis) to treat keratoconjunctivitis sicca (KCS) in a real-world setting.” PMID 16004673 ↗ Jul 2005

Show 132 more sources