drugset
Drugs / Prednisolone
last change 11 days ago re-read 8 days ago

Prednisolone

also known as Prednisolone acetate · Pred Forte · PRDL · Prednisolone Sodium Phosphate · Nanocort · PRED · prednisolone phosphate · Aprednislon · +19 more

Other / unclassified

Developed for
lymphoma · chronic obstructive pulmonary disease · rheumatoid arthritis · asthma · diffuse large B-cell lymphoma · cataract · leukemia · alcoholic hepatitis
+224 more · allergic bronchopulmonary aspergillosis · Hodgkins lymphoma · IgA glomerulonephritis · infantile spasms · adult acute lymphoblastic leukemia · allergic rhinitis · Bell's palsy · conjunctivitis · glaucoma · nephrotic syndrome · nephrotic syndrome of childhood - steroid sensitive · pulpitis · acute lymphoblastic leukemia · adrenocortical insufficiency · anterior uveitis · atopic eczema · autoimmune thrombocytopenic purpura · cataract 50 with or without glaucoma · Duchenne muscular dystrophy · granulomatosis with polyangiitis · hemangioma · herpes simplex virus keratitis · HIV infectious disease · immune reconstitution inflammatory syndrome · infertility disorder · lupus nephritis · lymphoblastic lymphoma · microscopic polyangiitis · minimal change disease · obstructive sleep apnea syndrome · polymyalgia rheumatica · pregnancy loss, recurrent, 4 · pterygium · schizophrenia · senile cataract · Acanthamoeba keratitis · acute apical periodontitis · acute asthma · acute bronchiolitis · acute leukemia · acute liver failure · allergic disease · anaplastic large cell lymphoma · ankylosing spondylitis · anosmia · autoimmune thrombocytopenia · B-cell acute lymphoblastic leukemia · B-cell non-Hodgkin lymphoma · biliary atresia · bronchiolitis · Burkitt lymphoma · cardiac sarcoidosis · childhood acute lymphoblastic leukemia · childhood onset asthma · chronic conjunctivitis · chronic graft versus host disease · chronic hepatitis B virus infection · chronic rhinosinusitis · classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency · classic Hodgkin lymphoma · cocaine dependence · contact dermatitis · corneal edema · COVID-19 · cranial nerves, recurrent paresis of · Crohn disease · dermatitis · diabetic retinopathy · drug-induced liver injury · eosinophilic pneumonia · epilepsy · estrogen-receptor positive breast cancer · female breast carcinoma · fibrotic hypersensitivity pneumonitis · follicular lymphoma · frozen shoulder · generalized myasthenia gravis · giant papillary conjunctivitis · gout · granulomatous mastitis · Graves disease · habitual spontaneous abortion · hypersensitivity reaction disease · idiopathic membranous glomerulonephritis · intrinsic cardiomyopathy · ischemic stroke · Kawasaki disease · keratoconjunctivitis · Langerhans cell histiocytosis specific to childhood · language disorder · leprosy · lipoma · lymph node tuberculosis · lymphoid leukemia · macular retinal edema · male infertility · membranous glomerulonephritis · mixed phenotype acute leukemia · mucous membrane pemphigoid · Mycoplasma pneumoniae pneumonia · myocarditis · nasal cavity polyp · neoplasm of mature B-cells · neoplasm of mediastinum · non-Hodgkin lymphoma · non-infectious anterior uveitis · opiate dependence · osteoarthritis, knee · osteoporosis · otitis media with effusion · pediatric arterial ischemic stroke · peripheral T-cell lymphoma, not otherwise specified · plasma cell myeloma · pleural tuberculosis · pneumonia · pregnancy disorder with abortive outcome · preretinal fibrosis · prostate cancer · psoriasis · psoriatic arthritis · pulmonary sarcoidosis · retinal vein occlusion · rheumatic fever · rheumatic heart disease · schizoaffective disorder · schizophreniform disorder · sciatica · seborrheic dermatitis · small intestine cancer · soft tissue sarcoma · status asthmaticus · sudden sensorineural hearing loss · T-cell acute lymphoblastic leukemia · temporal arteritis · tonsillitis · transplant rejection · tuberculosis · type 2 diabetes mellitus · ulcerative colitis · urticaria · uveitis · vestibular neuronitis · viral encephalitis · ALK-negative anaplastic large cell lymphoma · anaphylaxis · angioimmunoblastic T-cell lymphoma · anti-neutrophil cytoplasmic antibody-associated vasculitis · atherosclerosis · autoimmune hemolytic anemia · carpal tunnel syndrome · celiac disease · chorioretinitis · Coats disease · corneal disorder · corneal infection · corneal ulcer · croup · cystoid macular edema · diabetic macular edema · disease related to solid organ transplantation · drug allergy · dry eye syndrome · enteropathy-associated T-cell lymphoma · erythema nodosum · esophageal disorder · exfoliation syndrome · exudative vitreoretinopathy · eye adnexa disorder · eye infectious disorder · female infertility · food allergy · glaucomatocyclitic crisis · Hashimoto thyroiditis · headache disorder · hepatosplenic T-cell lymphoma · hypersensitivity pneumonitis · hypospadias · idiopathic nephrotic syndrome · infectious disease with sepsis · inflammation of heart layer · interstitial lung disease · iritis · juvenile chronic polyarthritis · juvenile idiopathic arthritis · kaposiform hemangioendothelioma · Kasabach-Merritt syndrome · keratoconus · kidney disorder · Langerhans cell histiocytosis · lichen planus, oral · liver disorder · long COVID-19 · lumbar disk disease · mouth disorder · myopathy · non-arteritic anterior ischemic optic neuropathy · open-angle glaucoma · oral erosive lichen · orbital pseudotumor · osteoarthritis · periapical periodontitis · pericardial tuberculosis · pituitary deficiency · pneumocystosis · polyarticular juvenile rheumatoid arthritis · polycystic ovary syndrome · post-COVID-19 disorder · prostate carcinoma · prostate neoplasm · respiratory tract infectious disorder · retinal lattice degeneration · retinal perforation · rhegmatogenous retinal detachment · sarcoidosis · sensorineural hearing loss disorder · stomatitis · subacute thyroiditis · systemic sclerosis · Takayasu arteritis · tracheal stenosis · uveal disorder · vernal keratoconjunctivitis · vestibular disorder · wet macular degeneration
Investigated by
GlaxoSmithKline · Asan Medical Center · Medical Research Council · AstraZeneca · Children's Cancer and Leukaemia Group · EMS
+344 more · Imperial College London · Post Graduate Institute of Medical Education and Research, Chandigarh · University College, London · Ann & Robert H Lurie Children's Hospital of Chicago · Assiut University · Bristol-Myers Squibb · Cairo University · Children's Hospital of Fudan University · European Organisation for Research and Treatment of Cancer - EORTC · Goethe University · Institute of Liver and Biliary Sciences, India · Leiden University Medical Center · Lymphoma Trials Office · National Cancer Institute (NCI) · Novartis · Seoul National University Hospital · Sparrow Pharmaceuticals · Academic Medical Center - University of Amsterdam · Amsterdam UMC, location VUmc · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Bausch & Lomb Incorporated · Cancer Research UK · Charite University, Berlin, Germany · Chonnam National University Hospital · Deutsche Krebshilfe e.V., Bonn (Germany) · European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma · Fovea Pharmaceuticals SA · Hamamatsu University · Isala · Johann Wolfgang Goethe University Hospital · Karolinska Institutet · Merck Sharp & Dohme LLC · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Northwestern University · ORA, Inc. · Ocular Therapeutix, Inc. · Radboud University Medical Center · Samsung Medical Center · Seoul St. Mary's Hospital · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Study Group of Medical Tumour Therapy (AGMT) · Technical University Dresden · The First Hospital of Jilin University · The Hospital for Sick Children · University Medical Center Groningen · University of Aarhus · University of Birmingham · University of California, San Francisco · University of Cambridge · University of Erlangen-Nürnberg Medical School · University of Southampton · University of Turku · Wayne State University · Zalicus · Aalborg University Hospital · Aarhus University Hospital · AbbVie · Academisch Ziekenhuis Groningen · Academy of Finland · Acute Leukemia French Association · Ain Shams University · Aldeyra Therapeutics, Inc. · Alexion Pharmaceuticals, Inc. · All India Institute of Medical Sciences · All India Institute of Medical Sciences, Bhubaneswar · Alrijne Hospital · Ameera Gamal Abdelhameed · Amgen · Amphia Hospital · Amsterdam University Medical Center · Anne M. Connolly · Aravind Eye Hospitals, India · Ardabil University of Medical Sciences · all 350 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) PEDIAPRED — 1998-12-17 fda.gov ↗
Label expansion US (FDA) OMNIPRED — 1995-08-29 fda.gov ↗
Approved US (FDA) METICORTELONE — 1955-05-22 fda.gov ↗

Trials 268 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05639127 Nov 2022 adrenocortical insufficiency University Medical Center Groningen Unknown No outcome recorded
Phase 116 trials
Phase 1 NCT07226635 Oct → Dec 2025 — Sparrow Pharmaceuticals Completed No outcome recorded
Phase 1 NCT06474416 Sep 2023 → Oct 2025 overdue herpes simplex virus keratitis Shanghai BDgene Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT06281236 Feb 2022 → Mar 2025 polymyalgia rheumatica Sparrow Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT07806357 Jun 2018 → Dec 2019 leprosy Chittagong Medical College Completed No outcome recorded
Phase 1 NCT02512575 Nov 2015 → Sep 2016 rheumatoid arthritis AstraZeneca Completed No outcome recorded
Phase 1 NCT01831505 Nov 2012 → Jul 2013 lymphoma Presage Biosciences Completed No outcome recorded
Phase 1 NCT01734759 Nov 2012 → Jan 2013 — Mayo Clinic Completed No outcome recorded
Phase 1 NCT01762787 Aug 2010 → Jan 2011 — GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00920660 Apr → Jun 2009 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT03198013 Nov 2008 → May 2009 — Bristol-Myers Squibb Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT07454772 Mar 2026 → Apr 2027 expected granulomatous mastitis All India Institute of Medical Sciences, Bhubaneswar Not yet recruiting No outcome recorded
Phase 1/2 NCT05328414 Mar 2022 → Mar 2023 anosmia Deraya University Completed No outcome recorded
Phase 1/2 NCT04300556 Aug 2020 → Aug 2030 expected cancer Eisai Inc. Recruiting No outcome recorded
Phase 1/2 NCT00624416 Oct 2007 → Mar 2009 lipoma Pennington Biomedical Research Center Completed No outcome recorded
Phase 1/2 NCT00032149 Oct 2001 → ? lymphoma Lymphoma Trials Office Unknown No outcome recorded
Phase 256 trials · 2 met primary · 2 missed
Phase 2 NCT07588698 Nov 2026 → Aug 2028 expected diffuse large B-cell lymphoma Carrie Ho, MD Not yet recruiting No outcome recorded
Phase 2 NCT06421597 Nov 2024 → Mar 2026 overdue osteoporosis Odense University Hospital Active not recruiting No outcome recorded
Phase 2 NCT06388564 Oct 2024 → Jun 2027 expected chronic graft versus host disease Incyte Corporation Active not recruiting No outcome recorded
Phase 2 NCT06614348 Oct 2024 → Jun 2025 overdue cataract 50 with or without glaucoma, senile cataract Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT06365853 Jul 2024 → Jun 2026 overdue ovarian cancer AbbVie Recruiting No outcome recorded
Phase 2 NCT05827549 Apr 2024 → Dec 2032 expected acute lymphoblastic leukemia Ho Joon Im Recruiting No outcome recorded
Phase 2 NCT05436652 Jul 2022 → Apr 2025 polymyalgia rheumatica Sparrow Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04862221 Feb 2022 → Aug 2026 overdue acute liver failure, hepatic encephalopathy, immune dysregulation, autoimmunity, and autoinflammation National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Recruiting No outcome recorded
Phase 2 NCT04098718 Mar 2021 → Feb 2024 asthma, chronic obstructive pulmonary disease University of Oxford Unknown Met primary
Phase 2 NCT04556760 Nov 2020 → Jun 2021 type 2 diabetes mellitus AstraZeneca Completed Mixed
Phase 2/314 trials · 3 missed
Phase 2/3 NCT05570409 Mar 2023 → Apr 2025 intrinsic cardiomyopathy LMU Klinikum Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT05283954 May → Jun 2022 COVID-19 Oriol Mitja Withdrawn No outcome recorded Stop: Business
Phase 2/3 NCT04563559 Nov 2020 → Nov 2021 cataract, glaucoma Duke University Withdrawn No outcome recorded
Phase 2/3 NCT04744623 Sep → Dec 2020 mucous membrane pemphigoid Tanta University Unknown No outcome recorded
Phase 2/3 NCT04124822 May 2018 → Jul 2019 acute apical periodontitis Dow University of Health Sciences Completed No outcome recorded
Phase 2/3 NCT02662283 May → Nov 2016 IgA glomerulonephritis Sun Yat-sen University Unknown No outcome recorded
Phase 2/3 NCT01621321 Jun 2013 → Apr 2016 allergic bronchopulmonary aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
Phase 2/3 NCT01395251 Feb 2012 → Nov 2014 rheumatoid arthritis Rheumazentrum Ruhrgebiet Completed No outcome recorded
Phase 2/3 NCT01590173 Jan 2012 → Jul 2016 infertility disorder National and Kapodistrian University of Athens Completed No outcome recorded
Phase 2/3 NCT01321827 Apr 2011 → Mar 2013 allergic bronchopulmonary aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh Completed Missed primary
Phase 361 trials · 6 met primary · 5 missed
Phase 3 NCT07830108 Dec 2026 → Dec 2034 expected rheumatic fever, rheumatic heart disease Starship Child Health, Te Toka Tumai Auckland Not yet recruiting No outcome recorded
Phase 3 NCT07700238 Aug 2026 → Sep 2029 expected autoimmune thrombocytopenia Amgen Recruiting No outcome recorded
Phase 3 NCT07210008 Jun 2026 → Dec 2028 expected fibrotic hypersensitivity pneumonitis Assistance Publique - Hôpitaux de Paris Not yet recruiting No outcome recorded
Phase 3 NCT06956482 May → Aug 2026 overdue alcoholic hepatitis University Hospital, Lille Recruiting No outcome recorded
Phase 3 NCT06347536 Jan 2025 → Dec 2027 expected chronic obstructive pulmonary disease Guy's and St Thomas' NHS Foundation Trust Recruiting No outcome recorded
Phase 3 NCT05214911 Jul 2024 → Mar 2025 allergic rhinitis Eurofarma Laboratorios S.A. Completed No outcome recorded
Phase 3 NCT07450508 Apr → Oct 2024 classic Hodgkin lymphoma Cairo University Completed No outcome recorded
Phase 3 NCT06174922 Dec 2023 → Jun 2026 overdue allergic bronchopulmonary aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh Recruiting No outcome recorded
Phase 3 NCT05675410 May 2023 → Apr 2031 expected Hodgkins lymphoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 3 NCT03249844 Sep 2022 → Dec 2027 ischemic stroke University Hospital of Saint-Etienne Withdrawn No outcome recorded
Phase 473 trials · 7 met primary · 3 missed
Phase 4 NCT07221838 Mar 2026 → Aug 2027 expected generalized myasthenia gravis Alexion Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 4 NCT06676384 Feb 2025 → Aug 2029 expected IgA glomerulonephritis, chronic kidney disease, immunoglobulin A vasculitis Christian Medical College, Vellore, India Recruiting No outcome recorded
Phase 4 NCT06838559 Jan 2025 → Dec 2027 expected infantile spasms University of Colombo Active not recruiting No outcome recorded
Phase 4 NCT05514015 Mar 2024 → Sep 2026 overdue idiopathic membranous glomerulonephritis First Affiliated Hospital, Sun Yat-Sen University Recruiting No outcome recorded
Phase 4 NCT07291089 Feb 2024 → Nov 2025 cataract 50 with or without glaucoma, senile cataract Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
Phase 4 NCT05725512 Jan 2024 → Jul 2026 overdue habitual spontaneous abortion, pregnancy disorder with abortive outcome, pregnancy loss, recurrent, 4 Leiden University Medical Center Recruiting No outcome recorded
Phase 4 NCT04662723 May 2023 → Jun 2026 overdue IgA glomerulonephritis Schena Foundation Recruiting No outcome recorded
Phase 4 NCT05768204 Mar 2023 → Dec 2025 pneumonia Baoping XU Unknown No outcome recorded
Phase 4 NCT05698680 Jan 2023 → Feb 2026 gout University Medicine Greifswald Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT05444699 Oct 2022 → Dec 2026 expected acute bronchiolitis University of Oulu Recruiting No outcome recorded
Phase not applicable41 trials · 1 met primary · 5 missed
— NCT07565623 May 2026 → Dec 2027 expected HIV infectious disease, immune reconstitution inflammatory syndrome Shanghai Public Health Clinical Center Not yet recruiting Met primary
— NCT07275593 Nov 2024 → Apr 2025 acute asthma Muhammad Aamir Latif Completed No outcome recorded
— NCT06155760 Nov 2023 → Feb 2025 alcoholic hepatitis Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT06035081 Sep 2023 → Apr 2024 — University of Aarhus Completed No outcome recorded
— NCT05990985 Sep 2023 → Aug 2024 overdue diffuse large B-cell lymphoma The First Hospital of Jilin University Not yet recruiting No outcome recorded
— NCT05861440 May 2023 → Jul 2025 lymph node tuberculosis National Taiwan University Hospital Unknown No outcome recorded
— NCT06917768 Dec 2022 → Dec 2023 obstructive sleep apnea syndrome Hotel Dieu de France Hospital Completed No outcome recorded
— NCT05532111 Sep 2022 → Sep 2023 — RenJi Hospital Unknown No outcome recorded
— NCT05212740 Jan → Oct 2022 frozen shoulder Istanbul University Completed No outcome recorded
— NCT04713410 Dec 2020 → Sep 2022 nephrotic syndrome of childhood - steroid sensitive Shaheed Zulfiqar Ali Bhutto Medical University Unknown No outcome recorded
Phase not stated1 trial · 1 met primary
— NCT00517894 — lymphoma Study Group of Medical Tumour Therapy (AGMT) No longer available Met primary
Comparator or background therapy512 trials
Phase 0 NCT05620901 Comparator Feb 2023 → Feb 2025 Coats disease, exudative vitreoretinopathy, retinal lattice degeneration, retinal perforation +1 Lejla Vajzovic, MD, FASRS Completed Missed primary
Phase 0 NCT03491098 Comparator May 2018 → Apr 2019 otitis media with effusion Muteea Mubark Salmen Bakuwiri Unknown No outcome recorded
Phase 0 NCT03087968 Background Jul 2016 → Sep 2017 alcoholic hepatitis HepQuant, LLC Withdrawn No outcome recorded
Phase 1 NCT07572071 Background Aug 2025 → Aug 2028 expected Parkinson disease Royan Institute Recruiting No outcome recorded
Phase 1 NCT06483802 Background Nov 2024 → Oct 2025 Friedreich ataxia, cardiomyopathy Astellas Gene Therapies Withdrawn No outcome recorded
Show all 512 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 36

DateIssuerRelease
2026-03-09 Janssen Research & Development, LLC Regulatory European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC) jnj.com ↗
Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression.
2025-06-12 Impax Laboratories, LLC Regulatory Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte ® .
2024-09-25 Genentech, Inc. Results Positive Phase III Results for Genentech’s Gazyva Show Superiority to Standard Therapy Alone in People With Lupus Nephritis gene.com ↗
In the study, a higher proportion of people treated with Gazyva plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those treated with standard therapy alone.
2024-08-05 Lupin Limited Regulatory Lupin Receives Approval from U.S. FDA for Prednisolone Acetate Ophthalmic Suspension USP lupin.com ↗
2023-08-24 Merck Sharp & Dohme LLC Regulatory LYNPARZA® (olaparib)Plus Abiraterone and Prednisolone Approved in Japan for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with BRCA -mutated ( BRCA m) castration-resistant prostate cancer with distant metastasis (mCRPC).
2023-08-24 AstraZeneca Regulatory Lynparza plus abiraterone approved in Japan for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC).
2023-06-01 Merck Sharp & Dohme LLC Regulatory FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
2023-06-01 AstraZeneca Regulatory Lynparza plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
2023-04-28 Merck Sharp & Dohme LLC Regulatory Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCA m mCRPC patients, recommending against approval beyond this patient population.
2023-04-28 AstraZeneca Regulatory Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer astrazeneca.com ↗
The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation.
2023-03-02 Merck Sharp & Dohme LLC Regulatory Merck and AstraZeneca Provide Update on US Regulatory Review of LYNPARZA® (olaparib) for Use in Combination With Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The ODAC Meeting is scheduled for April 28, 2023.
2023-03-02 AstraZeneca Regulatory Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

All press releases naming this drug 38 releases

DateIssuerRelease

Evidence & citations 31 cited values

Every value below carries the sentence it was read from. 784 sources stand behind the page.

FieldValueCited text
Known as prednisolone “Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10:...” NCT07151456 ↗
674

“One hundred forty subjects received either a 0.59-mg FA intravitreal implant (n = 66) or standard of care (SOC; n = 74) with either systemic prednisolone or equivalent...” PMID 20079922 ↗ Jan 2010

“METHODS: Patients scheduled to undergo phacoemulsification and with no recognized CME risks (diabetic retinopathy, retinal vascular disease, or macular abnormality) were...” PMID 18599019 ↗ Jul 2008

“Patients initially received one 21-day cycle of standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP; rituximab 375 mg/m2, cyclophosphamide...” PMID 30948276 ↗ Apr 2019

“All enrolled patients will first complete a total of 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy (Rituximab + Cyclophosphamide + Doxorubicin + Prednisolone)...” NCT05874778 ↗

“Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg...” NCT00425438 ↗

“Children received prednisolone at a dose of 60 mg/m2 per day for 4-8 weeks or less if they reached absence of proteinuria for 3 consecutive days, followed by 40 mg/m2 on...” NCT06860620 ↗

“This study evaluates the addition of Acalabrutinib to current standard therapy of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) for patients...” NCT04546620 ↗

“The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1),...” NCT01279902 ↗

“Prednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3...” NCT06732622 ↗

“Prednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3...” NCT06280794 ↗

Show 664 more sources
Known as Aprednislon ClinicalTrials.gov intervention name — accepted as the source's own label NCT00888901 ↗
Known as Deltacortril “Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)” NCT04921033 ↗
Known as Nanocort “Two weekly IV infusions of 150 mg Nanocort (PEG-liposomal prednisolone sodium phosphate).” NCT01647685 ↗
1

“PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®)” NCT01601106 ↗
Known as NSC-9900 “PRDL Prednisolone, NSC-9900” NCT00002576 ↗
Known as PDN “prednisolone (PDN) or PDN monotherapy” PMID 40781621 ↗ Aug 2025
Known as PRDL “Patients receive oral prednisolone (PRDL) twice daily or methylprednisolone IV over 1 hour every 12 hours on days 1-7.” NCT00003728 ↗
6

“methotrexate (MTX) and prednisolone (PRDL) intrathecally (IT)” NCT00550992 ↗

“oral prednisolone (PRDL) 3 times a day on days 1-7” NCT00002531 ↗

“oral prednisolone (PRDL) on days 1-5” NCT00003815 ↗

“PRDL Prednisolone, NSC-9900” NCT00002757 ↗

“PRDL Prednisolone, NSC-9900” NCT00002576 ↗

“oral prednisolone (PRDL)” NCT00025064 ↗
Known as PRED “prednisolone (PRED) (0.8mg/kg/d) plus mycophenolate mofetil (MMF) (1g bd) as induction-maintenance therapy” NCT02954939 ↗
1

“80 mg of oral prednisolone (PRED) every day (q.d.)” PMID 21216851 ↗ Jan 2011
Known as Pred Fort “Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan)” NCT01227876 ↗
Known as Pred Forte “prednisolone acetate ophthalmic suspension 1% (Pred Forte; Allergan, Inc., Irvine, CA) for endogenous anterior uveitis.” PMID 20809807 ↗ Oct 2010
12

“twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone” NCT00469781 ↗

“Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of” NCT04426734 ↗

“topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)” NCT02625467 ↗

“Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]” NCT04362241 ↗

“topical prednisolone acetate 1% (PredForte) eye drops” NCT06235567 ↗

“1.0% prednisolone acetate, Pred Forte” NCT07136805 ↗

“Prednisolone Acetate 1% (Pred Forte®)” NCT00833495 ↗

“Steriod eye drop: Pred Forte” NCT01673191 ↗

NCT00478036 ↗

NCT03320434 ↗

Show 2 more sources
Known as pred forte (Prednisolone acetate1% ) “pred forte (Prednisolone acetate1% )” NCT02206789 ↗
Known as Pred Mild “Prednisolone Acetate 0.12% (Pred Mild®)” NCT00833495 ↗
Known as PredA “Prednisolone acetate (PredA) 1% ophthalmic solution” NCT01769352 ↗
Known as Prednefrin “Prednefrin® SF. Prednisolone Acetate 1%.” NCT03693989 ↗
Known as Prednefrin SF “Prednefrin® SF. Prednisolone Acetate 1%.” NCT03693989 ↗
Known as Prednesol 5mg “Prednesol 5mg Tablets (Phoenix Labs Ltd). Pink, circular, flat, bevel-edged scored tablets containing 5 mg of prednisolone as prednisolone sodium phosphate.” NCT03698630 ↗
Known as Prednisolon “Prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d (5 mg tabletti, Prednisolon ®, Leiras, Finland).” NCT00494624 ↗
Known as Prednisolone (as Acetate) “Drug: Prednisolone (as Acetate)” NCT04705584 ↗
Known as Prednisolone acetate “An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week...” NCT02819908 ↗
92

“The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative...” NCT01475643 ↗

“To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on...” NCT00698724 ↗

“Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by 4 times daily for 2 weeks, then twice daily for 2 weeks and finally once daily for 2 weeks.” NCT04705584 ↗

“All patient will be treated with Topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .” NCT04451239 ↗

“Topical steroid medications to be used in this study include Prednisolone acetate 1.0% or Prednisolone sodium phosphate 1%.” NCT03626376 ↗

“standard topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and Prednisolone acetate 1%.” NCT03578276 ↗

“Patients were randomized 2:1 to topical TRS01 1% or prednisolone acetate 1% administered 4 times daily for 28 days.” PMID 41485727 ↗ Jan 2026

“Prednisolone acetate 1% ophthalmic solution: one drop to the operative eye four times daily for 1 month, then stop” NCT05157113 ↗

“Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.” NCT06474416 ↗

“Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.” NCT06474442 ↗

Show 82 more sources
Known as Prednisolone Acetate Ophthalmic Suspension “Prednisolone Acetate Ophthalmic Suspension” NCT06474416 ↗
Known as Prednisolone Fort “2 weeks of oral prednisolone 1mg/kg/day (Prednisolone Fort; Sina Daroo, Iran” NCT02439866 ↗
Known as Prednisolone metasulfobenzoate sodium “The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).” NCT04652739 ↗
Known as prednisolone phosphate “prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week” NCT00324168 ↗
1

NCT00000138 ↗
Known as Prednisolone Sodium Phosphate “Topical steroid medications to be used in this study include Prednisolone acetate 1.0% or Prednisolone sodium phosphate 1%.” NCT03626376 ↗
6

“PEG-liposomal Prednisolone Sodium Phosphate (Nanocort) in Atherosclerotic Tissue” NCT01647685 ↗

NCT03484507 ↗

NCT03698630 ↗

NCT03491098 ↗

NCT05444699 ↗

NCT01730872 ↗
Known as Prezolon “5 mg prednisolone p.os (Prezolon; Nycomed Hellas SA) were to be initiated on the first day of injections in both protocols until the pregnancy test” NCT01590173 ↗