prednisolone

Trade name: hydeltra

Small moleculeapproved

Approved

Jul 25, 1956

Meprednisone, also known as NSC-63278 and Betapar, is a glucocorticoid receptor agonist.It has anti-inflammatory and immunosuppressive activity. It was approved since 1978, but its marketing in USA was discontinied since. Meprednisone is marketed in Argentina under trade name Copytren for treatment of rheumatic diseases, diseases of collagen, dermatological, gastrointestinal, respiratory and ophtalmological diseases. — NCATS

Clinical trial activity

414 trials · 411 clinical orgs · 30 marketing orgs

Phase 1

Phase 2

220

Phase 3

106

Phase 4

Earliest trial started Mar 12, 1999 (NCT00001880)

Timeline

1950s

Jul 25, 1956
Earliest FDA Approval
Jul 25, 1956
Merck — NDA Secondary Org

1970s

Dec 19, 1973
Novartis — Marketing Organization
Jan 29, 1974
Watson Pharmaceuticals — Marketing Organization
Aug 21, 1974
Akorn, Inc. — Marketing Organization
Nov 22, 1974
Johnson and Johnson — Marketing Organization
Jan 26, 1978
Schering — First NDA Organization
Jan 26, 1978
Schering — NDA Secondary Org
Jan 26, 1978
Schering — NDA Organization
Jan 26, 1978
Schering-Plough — NDA Secondary Org

1980s

May 28, 1986
Seton Pharm — NDA Secondary Org
Aug 26, 1988
Novartis — NDA Secondary Org

1990s

Oct 24, 1991
Alcon — Marketing Organization
Oct 24, 1991
Nestle — Marketing Organization
May 27, 1993
Sandoz — Marketing Organization
Jul 29, 1994
Bausch & Lomb — Marketing Organization
Jan 1, 1999
Earliest Phase 2 Sponsor(trial)

2000s

Dec 14, 2000
Advanz Pharma — NDA Secondary Org
Dec 14, 2000
Advanz Pharma — Marketing Organization
Jun 28, 2002
Wockhardt — Marketing Organization
Jun 28, 2002
Xttrium Laboratories — Marketing Organization
Jul 12, 2002
Medicis — Marketing Organization
Jul 12, 2002
Bausch Health Companies — Marketing Organization
Dec 23, 2002
Pharmaceutical Associates — Marketing Organization
Dec 23, 2002
We Pharma Ltd — Marketing Organization
Mar 26, 2003
Hi Tech Pharmaceuticals — Marketing Organization
May 25, 2004
Chartwell Pharmaceuticals — Marketing Organization
May 24, 2005
Nesher Pharms — Marketing Organization
Oct 31, 2007
Vintage — Marketing Organization
Oct 31, 2007
Apax Partners — Marketing Organization
Mar 10, 2009
Amneal Pharmaceuticals — Marketing Organization

2010s

Sep 13, 2010
Mission Pharmacal — Marketing Organization
Jan 1, 2011
Earliest Phase 1 Sponsor(trial)
Apr 10, 2013
Mylan — Marketing Organization
Apr 10, 2013
Rising Pharmaceuticals — Marketing Organization
Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
Dec 20, 2016
Edenbridge Pharms — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Glucocorticoid receptorAGONIST
NR3C1 agonist
- Glucocorticoid receptor (NR3C1) ↗

Combination products

neo-hydeltrasol
with neomycin
sulster
with sulfacetamide

Approval history

approvedJul 25, 1956

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12C=CC(=O)C=C1CC[C@@H]1[C@@H]2[C@@H](O)C[C@@]2(C)[C@H]1CC[C@]2(O)C(=O)COP(=O)(O)O

Mol. weight: 440.43 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral, Topical
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

11 beta,17 alpha,21-trihydroxypregna-1,4-diene-3,20-dione 21-tert-butyl acetate
16-methylprednisone
acepreval
betalone
betanisona
betapar
betapar
betapar
betapar
bitanisone
codelcortone-tba
etaproctene
liposomal prednisolone
meprednisone
meprednisone
meprednisone
meprednisone
meprednisone
meprednisone
meprednisone
meprednisone
meprednisone
meprednisone
nanocort
pediapred
pediapred
pediapred
peg-liposomal prednisolone
prednisolamate
prednisolamate
prednisolamate hydrochloride
prednisolone 17-valerate 21-acetate
prednisolone 21-acetate 17-valerate
prednisolone 21-all-trans-farnesylate
prednisolone 21-diethylaminoacetate
prednisolone 21-diethylaminoacetate
prednisolone 21-diethylaminoacetate
prednisolone 21-phosphate sodium
prednisolone bisuccinate
prednisolone butylacetate
prednisolone butylacetate
prednisolone butylacetate
prednisolone butylacetate
prednisolone farnesylate
prednisolone farnesylate
prednisolone farnesylate
prednisolone farnesylate
prednisolone hemisuccinate
prednisolone metasulfobenzoate
prednisolone metasulfobenzoate sodium
prednisolone metazoate
prednisolone phosphate
prednisolone phosphate
prednisolone phosphate
prednisolone phosphate, monosodium salt, (11beta)-isomer
prednisolone phosphate sodium
prednisolone phosphate, sodium salt, (11beta)-isomer
prednisolone phosphoric acid
prednisolone phosphoric acid
prednisolone phosphoric acid
prednisolone sodium metasulfobenzoate
prednisolone sodium metazoate
prednisolone sodium phosphate
prednisolone sodium phosphate
prednisolone sodium phosphate
prednisolone sodium phosphate
prednisolone sodium phosphate
prednisolone sodium phosphate
prednisolone sodium phosphate
prednisolone succinate
prednisolone succinate
prednisolone succinate
prednisolone succinate
prednisolone succinate
prednisolone sulfobenzoate
prednisolone sulfobenzoate
prednisolone sulfobenzoate
prednisolone sulfobenzoate
prednisolone sulfobenzoate
prednisolone tba
prednisolone tebutate
prednisolone tebutate
prednisolone tebutate
prednisolone tebutate
prednisolone tebutate
prednisolone tebutate
prednisolone tebutate
prednisolone tebutate
prednisolone tert-butylacetate
prednisolone tertiary butyl acetate
prednisolone valerate acetate
prednisolone valerate acetate
prednisolone valerate acetate
prednisolone valerate acetate
prednisolone valerate acetate
predsol
predsol
predsol
pregna-1,4-diene-3,20-dione, 21-(3,3-dimethyl-1-oxobutoxy)-11,17-dihydroxy-, (11 beta)-
sch-4358
sch-4358
sodium prednisolone phosphate

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07210008	Phase 3	Jun 1, 2026	Assistance Publique - Hôpitaux de Paris
NCT07228624	Phase 2	May 1, 2026	Incyte, University of Washington
NCT07227584	Phase 2	Apr 30, 2026	Harvard University
NCT07072585	Phase 2/Phase 3 (Phase 3)	Mar 30, 2026	National Cancer Institute (NCI)
NCT07294677	Phase 1/Phase 2 (Phase 2)	Mar 17, 2026	University of Chicago
NCT07281807	Phase 4	Jan 1, 2026	Shaheed Zulfiqar Ali Bhutto Medical University
NCT07221838	Phase 4	Dec 31, 2025	Alexion
NCT07301138	Phase 2	Dec 15, 2025	Jiao Tong University
NCT07227428	Phase 4	Dec 1, 2025	Chung-Ang University, Gachon University, Seoul National University
NCT07252271	Phase 4	Dec 1, 2025	Chinese University of Hong Kong
NCT07214779	Phase 3	Dec 1, 2025	ENGOT Foundation, GOG Foundation, Inc., Incyte
NCT07230626	Phase 3	Nov 20, 2025	Shijiazhuang Pharma Group (CSPC)
NCT07015242	Phase 2	Nov 6, 2025	Bristol-Myers Squibb
NCT06956482	Phase 3	Oct 31, 2025	University of Lille
NCT07172659	Phase 2	Oct 31, 2025	Medicines Development for Global Health
NCT06918431	Phase 2	Oct 10, 2025	City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07176390	Phase 2	Oct 8, 2025	Merck
NCT07226635	Phase 1	Oct 3, 2025	Sparrow Pharmaceuticals
NCT07136805	Phase 3	Oct 1, 2025	VivaVision Biotech, Inc
NCT07138898	Phase 2	Sep 30, 2025	New York University

Showing 20 of 414 trials

Page 1 / 21

Organizations

Research & Development (411)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Cancer Institute (NCI)	Government	20	15	3	2003
Ocular Therapeutix, Inc.	For profit	14	1	2	2019
Chinese Academy of Medical Sciences	Academic/Hospital	12	11	4	2020
Harvard University	Academic/Hospital	8	6	4	2020
Postgraduate Institute of Medical Education and Research	Academic/Hospital	8	7	3	2009
Assiut University	Academic/Hospital	7	7	5	2017
Cairo University	Academic/Hospital	7	6	5	2018
Jiao Tong University	Academic/Hospital	7	6	4	2022
St. Jude Children's Hospital	Academic/Hospital	7	7	3	2022
Fudan University	Academic/Hospital	6	6	3	2019
Merck	For profit	6	5	3	2018
Regeneron	For profit	6	4	1	2018
Sanofi	For profit	6	5	2	2017
Tanta University	Academic/Hospital	6	5	3	2020
University of Amsterdam	Academic/Hospital	6	3	2	2011
AbbVie	For profit	5	2	3	2019
AstraZeneca	For profit	5	4	2	2018
Leiden University	Academic/Hospital	5	4	4	2015
Aarhus University	Academic/Hospital	4	4	2	2018
Bangladesh Medical University	Academic/Hospital	4	4	2	2015

411 organizations

Page 1 / 21

Marketing (37)

Organization	Org type	Relationship	Date
Advanz Pharma	For profit	NDA2	Dec 14, 2000
Advanz Pharma	For profit	MKTG	Dec 14, 2000
Akorn, Inc.	For profit	MKTG	Aug 21, 1974
Alcon	For profit	MKTG	Oct 24, 1991
Amneal Pharmaceuticals	For profit	MKTG	Mar 10, 2009
Amneal Pharmaceuticals	For profit	SYN	Oct 25, 2022
Apax Partners	For profit	MKTG	Oct 31, 2007
Bausch & Lomb	For profit	MKTG	Jul 29, 1994
Bausch Health Companies	For profit	MKTG	Jul 12, 2002
Chartwell Pharmaceuticals	For profit	MKTG	May 25, 2004
Edenbridge Pharms	For profit	MKTG	Dec 20, 2016
Hi Tech Pharmaceuticals	For profit	MKTG	Mar 26, 2003
Johnson and Johnson	For profit	MKTG	Nov 22, 1974
Medicis	For profit	MKTG	Jul 12, 2002
Merck	For profit	NDA2	Jul 25, 1956
Mission Pharmacal	For profit	MKTG	Sep 13, 2010
Mylan	For profit	MKTG	Apr 10, 2013
Nesher Pharms	For profit	MKTG	May 24, 2005
Nestle	For profit	MKTG	Oct 24, 1991
Novartis	For profit	MKTG	Dec 19, 1973
Novartis	For profit	NDA2	Aug 26, 1988
Pharmaceutical Associates	For profit	MKTG	Dec 23, 2002
Pharmafair	For profit	MKTG	—
Rising Pharmaceuticals	For profit	MKTG	Apr 10, 2013
Sandoz	For profit	MKTG	May 27, 1993
Sandoz	For profit	SYN	May 27, 1993
Schering	For profit	NDA2	Jan 26, 1978
Schering	For profit	NDA	Jan 26, 1978
Schering	For profit	MKTG	—
Schering-Plough	For profit	NDA2	Jan 26, 1978
Seton Pharm	For profit	NDA2	May 28, 1986
Vintage	For profit	SYN	May 26, 2009
Vintage	For profit	MKTG	Oct 31, 2007
Watson Pharmaceuticals	For profit	MKTG	Jan 29, 1974
We Pharma Ltd	For profit	MKTG	Dec 23, 2002
Wockhardt	For profit	MKTG	Jun 28, 2002
Xttrium Laboratories	For profit	MKTG	Jun 28, 2002