methylprednisolone

Trade name: medrol

Small moleculeapproved

Approved

Oct 24, 1957

Methylprednisolone is a prednisolone derivative with similar anti-inflammatory and immunosuppressive action. It is adjunctive therapy for short-term administration in rheumatoid arthritis. It is indicated in the following conditions: endocrine disorders, rheumatic disorders, collagen diseases, allergic states etc. Methylprednisolone is marketed in the USA and Canada under the brand names Medrol and Solu-Medrol. Methylprednisolone is a GR receptor agonist. — NCATS

Clinical trial activity

907 trials · 665 clinical orgs · 46 marketing orgs

Phase 1
122
Phase 2
454
Phase 3
236
Phase 4
195

Earliest trial started Mar 1, 1988 (NCT01177371)

Timeline

1950s

  1. Oct 24, 1957

    Pharmacia & Upjohn — Earliest FDA Approval

  2. Oct 24, 1957

    Pharmacia & Upjohn — NDA Secondary Org

  3. Oct 24, 1957

    Pharmacia & Upjohn — NDA Organization

  4. Oct 24, 1957

    Pfizer — Marketing Organization

  5. Oct 24, 1957

    Pfizer — NDA Secondary Org

1960s

  1. Dec 7, 1964

    Pharmacia & Upjohn — Marketing Organization

1970s

  1. Mar 28, 1978

    Hospira — Marketing Organization

  2. Dec 6, 1979

    Belmar Pharmacy — Marketing Organization

1980s

  1. Feb 15, 1980

    Elkins Sinn — Marketing Organization

  2. Jul 28, 1981

    Invatech — Marketing Organization

  3. Jul 28, 1981

    Sandoz — Marketing Organization

  4. Jul 28, 1981

    Rising Pharmaceuticals — Marketing Organization

  5. Feb 9, 1982

    Watson Pharmaceuticals — Marketing Organization

  6. Jun 25, 1982

    Organon — Marketing Organization

  7. Feb 21, 1984

    Duramed Research — Marketing Organization

  8. Jun 8, 1984

    Abraxis — Marketing Organization

  9. Jan 1, 1988

    Earliest Phase 2 Sponsor(trial)

  10. Jan 1, 1988

    Earliest Phase 3 Sponsor(trial)

  11. Apr 25, 1988

    Par Pharmaceuticals — Marketing Organization

1990s

  1. Feb 22, 1991

    Abbott — Marketing Organization

  2. Jan 1, 1994

    Earliest Phase 1 Sponsor(trial)

  3. Oct 31, 1997

    Jubilant Innovation Ltd. — Marketing Organization

  4. Oct 31, 1997

    Novartis — Marketing Organization

  5. Dec 22, 1998

    Endo Pharmaceuticals — Marketing Organization

  6. Dec 22, 1998

    Vintage — Marketing Organization

  7. Dec 22, 1998

    PH HEALTH — Marketing Organization

2000s

  1. Jul 30, 2004

    Fresenius — Marketing Organization

  2. Feb 23, 2005

    Teva — Marketing Organization

  3. Feb 23, 2005

    Eu Yan Sang — Marketing Organization

  4. Feb 21, 2007

    Bedford Pharmaceuticals — Marketing Organization

2010s

  1. Dec 15, 2015

    Aurobindo Pharma — Marketing Organization

  2. Dec 15, 2015

    Eugia Pharma — Marketing Organization

  3. Feb 16, 2016

    Hikma — Marketing Organization

  4. Apr 23, 2018

    Zydus Discovery DMCC — Marketing Organization

  5. May 14, 2018

    Tianjin Tianyao Pharmaceuticals — Marketing Organization

  6. Jun 27, 2018

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  7. Jun 27, 2018

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  8. Jan 9, 2019

    Novast Labs — Marketing Organization

  9. Jan 9, 2019

    RiconPharma — Marketing Organization

  10. Jan 9, 2019

    Ingenus Pharmaceuticals — Marketing Organization

  11. Feb 22, 2019

    Lupin — Marketing Organization

  12. Feb 22, 2019

    Chartwell Pharmaceuticals — Marketing Organization

  13. May 20, 2019

    Amneal Pharmaceuticals — Marketing Organization

  14. Jun 27, 2019

    Praxgen Pharma — Marketing Organization

2020s

  1. Apr 20, 2021

    Tianjin Kingyork — Marketing Organization

  2. Jan 21, 2022

    Bristol-Myers Squibb — Marketing Organization

  3. Jan 3, 2023

    Wilshire Pharmaceuticals — Marketing Organization

  4. Jan 3, 2023

    Slayback Pharma Llc — Marketing Organization

  5. Jan 26, 2026

    Caplin Point Laboratories — Marketing Organization

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedOct 24, 1957

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Mol. weight
416.51 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 1-dehydro-6alpha-methylhydrocortisone
  • 1-dehydro-6alpha-methylhydrocortisone
  • 1-dehydro-6α-methylhydrocortisone
  • 1-dehydro-6α-methylhydrocortisone
  • 2b3-201
  • 4'-fluor-4-(4-methylpiperidino)-butyrophenone
  • (6alpha,11beta)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
  • (6alpha,11beta)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
  • 6alpha-methyl-11beta,17alpha,21-triol-1,4-pregnadiene-3,20-dione
  • 6alpha-methyl-11beta,17alpha,21-triol-1,4-pregnadiene-3,20-dione
  • 6alpha-methylprednisolone aceponate
  • 6-alpha-methylprednisone
  • 6-alpha-methylprednisone
  • (6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
  • (6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
  • acetyl-methylprednisolone
  • advantan
  • advantan
  • advantan
  • advantan
  • adventan
  • buronil
  • csl brand of methylprednisolone aceponate
  • delta(1)-6alpha-methylhydrocortisone
  • delta(1)-6alpha-methylhydrocortisone
  • depemedrone
  • depmedalone
  • depmedalone
  • depomedrol
  • depo medrol
  • depo medrol
  • depo-medrol
  • depo-medrol
  • depo-medrol
  • depomedrone
  • depomedrone
  • depo-medrone
  • depo-medrone
  • depo-medrone
  • depo-methylprednisolone
  • eunerpan
  • eunerpan
  • fg-5111
  • fg-5111
  • flubuperone
  • flubuperone
  • flubuperone
  • harmosin
  • italfarmaco brand of methylprednisolone aceponate
  • lexxema
  • libernal
  • medralone
  • medrate
  • medrate
  • medrol
  • medrol
  • medrol
  • medrol acetate
  • medrol acetate
  • medrol acetate
  • medrone
  • medrone
  • medrone
  • melneurin
  • melperomerck
  • melperon
  • melperon abz
  • melperon al
  • melperon azu
  • melperon beta
  • melperone
  • melperone
  • melperone
  • melperone
  • melperone
  • melperone
  • melperone
  • melperone
  • melperon fg 5111
  • melperon-neuraxpharm
  • melperon-ratiopharm
  • melperon-rph
  • melperon stada
  • melperon-teva
  • melperon von ct
  • mel-puren
  • methylenprednisolone
  • methylenprednisolone
  • methylorednisolone
  • methylperon
  • methylperone
  • methylprednisolon
  • methylprednisolon
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone
  • methylprednisolone 21-(8-(methyl-(2-sulfoethyl)amino)-1,8-dioxooctanoate)
  • methylprednisolone-21-acetate
  • methylprednisolone aceponate
  • methylprednisolone aceponate
  • methylprednisolone aceponate
  • methylprednisolone aceponate
  • methylprednisolone aceponate
  • methylprednisolone aceponate
  • methylprednisolone aceponate
  • methyl prednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate
  • methylprednisolone acetate, (11beta,16alpha)-isomer
  • methylprednisolone acetate, (11beta,16beta)-isomer
  • methylprednisolone hemisuccinate
  • methylprednisolone hemisuccinate
  • methylprednisolone hemisuccinate
  • methylprednisolone sodium succinate
  • methylprednisolone sodium succinate
  • methylprednisolone sodium succinate
  • methylprednisolone sodium succinate
  • methylprednisolone succinate
  • methylprednisolone succinate
  • methylprednisolone succinate
  • methylprednisolone succinate
  • methylprednisolone succinate
  • methylprednisolone succinate
  • methylprednisolone suleptanate
  • methylprednisolone suleptanate
  • methylprednisolone suleptanate
  • methylprednisolone suleptanate
  • methylprednisolone suleptanate
  • methylprednisolone suleptanate
  • methylprednisolone suleptanate sodium
  • methylprednisolone suleptanate sodium salt
  • methylprednisolonum
  • methylprednisolonum
  • methylprednisone
  • methylprednisone
  • methylprednisone
  • methylprednisone
  • methylprenisolone
  • methylprenisolone
  • methyprednislone
  • methyprednisolone
  • methyprednisolone
  • metilbetasone
  • metilprednisolona
  • metilprednisolona
  • metylperon
  • metylperon hydrochloride
  • mpso
  • neo-medrone
  • pnu-67590a
  • schering brand of methylprednisolone aceponate
  • solomet
  • solomet
  • solumedrol
  • solumedrol
  • solu-medrol
  • solu-medrol
  • u 67590a
  • u-67590a
  • u-67590a
  • u-67590a
  • u-67,590a
  • urbason
  • urbason
  • urbasone
  • urbasone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07075315Phase 3Jan 31, 2028Indian Council of Medical Research, Institute of Liver and Biliary Sciences, India
NCT07072585Phase 2/Phase 3 (Phase 3)Mar 30, 2026National Cancer Institute (NCI)
NCT07245355N/AFeb 1, 2026Suleyman Demirel University
NCT07267650N/AJan 1, 2026Turgutlu State Hospital
NCT07211399Early Phase 1 (Phase 1)Jan 1, 2026University of Pittsburgh
NCT07258771Phase 4Dec 31, 2025AbbVie, University of Michigan
NCT07265258Phase 4Dec 30, 2025Innovent Biologics (Suzhou) Co. Ltd.
NCT07287397Phase 1/Phase 2 (Phase 2)Dec 18, 2025Vector Y Therapeutics
NCT07208799Phase 2Dec 1, 2025Nishtar Medical University, University of Health Sciences Lahore
NCT07255248N/ANov 17, 2025Harvard University
NCT07054801Phase 2Nov 1, 2025University of California, San Francisco
NCT07270549Phase 1/Phase 2 (Phase 2)Nov 1, 2025CTNNB1 Foundation, University of Ljubljana
NCT07175649N/AOct 31, 2025Sun Yat-Sen University
NCT07158476Phase 4Oct 21, 2025St. Louis University
NCT07187037N/AOct 1, 2025Konya City Hospital
NCT07185633Phase 2Oct 1, 2025Soochow University
NCT07180277Phase 4Oct 1, 2025Zhangjiagang First People's Hospital
NCT07101445Phase 4Sep 24, 2025Emory University, Gamida Cell, National Cancer Institute (NCI)
NCT07175623N/ASep 16, 2025Konya City Hospital
NCT07052929Phase 1/Phase 2 (Phase 2)Sep 11, 2025Astellas
Showing 20 of 907 trials
Page 1 / 46

Organizations

Research & Development (665)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government631651993
University of CopenhagenAcademic/Hospital313041995
RocheFor profit292031999
University of Texas at HoustonAcademic/Hospital262151993
National Institute of Allergy and Infectious Diseases (NIAID)Government241841999
Capital Medical UniversityAcademic/Hospital231952010
NovartisFor profit201432002
Harvard UniversityAcademic/Hospital191351994
Northwestern UniversityAcademic/Hospital171551997
Sun Yat-Sen UniversityAcademic/Hospital171652007
PfizerFor profit14842003
AstellasFor profit131331999
Emory UniversityAcademic/Hospital13832006
GenentechFor profit13821998
University of MinnesotaAcademic/Hospital131331996
Bristol-Myers SquibbFor profit10332008
National Heart, Lung, and Blood Institute (NHLBI)Government10341994
People's Liberation Army of ChinaGovernment10752011
Assistance Publique - Hôpitaux de ParisAcademic/Hospital9932018
BiogenFor profit9722003
665 organizations
Page 1 / 34

Marketing (56)

OrganizationOrg typeRelationshipDate
AbbottFor profitMKTGFeb 22, 1991
AbraxisFor profitMKTGJun 8, 1984
Akorn, Inc.For profitMKTG
Amneal PharmaceuticalsFor profitSYNNov 9, 2016
Amneal PharmaceuticalsFor profitMKTGMay 20, 2019
Athenex, Inc.For profitMKTG
Aurobindo PharmaFor profitMKTGDec 15, 2015
Bedford PharmaceuticalsFor profitMKTGFeb 21, 2007
Belmar PharmacyFor profitMKTGDec 6, 1979
Bristol-Myers SquibbFor profitMKTGJan 21, 2022
Caplin Point LaboratoriesFor profitMKTGJan 26, 2026
Chartwell PharmaceuticalsFor profitMKTGFeb 22, 2019
Duramed ResearchFor profitMKTGFeb 21, 1984
Elkins SinnFor profitMKTGFeb 15, 1980
Endo PharmaceuticalsFor profitMKTGDec 22, 1998
Eu Yan SangFor profitMKTGFeb 23, 2005
Eugia PharmaFor profitMKTGDec 15, 2015
FreseniusFor profitMKTGJul 30, 2004
Heather PharmaFor profitMKTG
HikmaFor profitMKTGFeb 16, 2016
HospiraFor profitMKTGMar 28, 1978
HospiraFor profitSYNNov 25, 2008
Ingenus PharmaceuticalsFor profitMKTGJan 9, 2019
International MedicationFor profitMKTG
InvatechFor profitMKTGJul 28, 1981
Jubilant Innovation Ltd.For profitMKTGOct 31, 1997
LupinFor profitMKTGFeb 22, 2019
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGJun 27, 2018
NovartisFor profitMKTGOct 31, 1997
Novast LabsFor profitMKTGJan 9, 2019
OrganonFor profitMKTGJun 25, 1982
PH HEALTHFor profitMKTGDec 22, 1998
Par PharmaceuticalsFor profitSYNJan 21, 2022
Par PharmaceuticalsFor profitMKTGApr 25, 1988
PfizerFor profitMKTGOct 24, 1957
PfizerFor profitNDA2Oct 24, 1957
Pharmacia & UpjohnFor profitNDA2Oct 24, 1957
Pharmacia & UpjohnFor profitNDAOct 24, 1957
Pharmacia & UpjohnFor profitMKTGDec 7, 1964
Praxgen PharmaFor profitMKTGJun 27, 2019
Praxgen PharmaFor profitMKTGJun 27, 2019
RiconPharmaFor profitMKTGJan 9, 2019
Rising PharmaceuticalsFor profitMKTGJul 28, 1981
Sagent Pharmaceuticals, Inc.For profitMKTGJun 27, 2018
Sagent Pharmaceuticals, Inc.For profitSYNJul 18, 2011
SandozFor profitSYNJan 29, 2009
SandozFor profitMKTGJul 28, 1981
Slayback Pharma LlcFor profitMKTGJan 3, 2023
TevaFor profitMKTGFeb 23, 2005
TevaFor profitSYNNov 30, 1992
Tianjin KingyorkFor profitMKTGApr 20, 2021
Tianjin Tianyao PharmaceuticalsFor profitMKTGMay 14, 2018
VintageFor profitMKTGDec 22, 1998
Watson PharmaceuticalsFor profitMKTGFeb 9, 1982
Wilshire PharmaceuticalsFor profitMKTGJan 3, 2023
Zydus Discovery DMCCFor profitMKTGApr 23, 2018