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fludrocortisone

Trade name: florinef

Small moleculeapproved

Approved

Aug 18, 1955

Fludrocortisone, sold under the brand name Florinef among others, is a corticosteroid used to treat congenital adrenal hyperplasia, postural hypotension, and adrenal insufficiency. In adrenal insufficiency, it is generally taken together with hydrocortisone. Fludrocortisone is taken by mouth and is most commonly used in its acetate form. — Wikipedia

Clinical trial activity

46 trials · 66 clinical orgs · 9 marketing orgs

Phase 1
14
Phase 2
21
Phase 3
11
Phase 4
4

Earliest trial started Jan 1, 2005 (NCT00103597)

Timeline

1950s

  1. Aug 18, 1955

    Casper Pharma LLC — Earliest FDA Approval

  2. Aug 18, 1955

    Casper Pharma LLC — NDA Secondary Org

  3. Aug 18, 1955

    Casper Pharma LLC — NDA Organization

2000s

  1. Mar 18, 2002

    Impax Laboratories — Marketing Organization

  2. Jan 21, 2003

    Barr Laboratories — Marketing Organization

  3. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jul 22, 2011

    Hikma — Marketing Organization

2020s

  1. May 31, 2022

    Novitium Pharma — Marketing Organization

  2. May 31, 2022

    Ani Pharmaceuticals — Marketing Organization

  3. Oct 27, 2022

    Chartwell Pharmaceuticals — Marketing Organization

  4. Oct 16, 2024

    Zydus Discovery DMCC — Marketing Organization

  5. Feb 10, 2026

    HIBROW HLTHCARE — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 18, 1955

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12C[C@H](O)[C@@]3(F)[C@@H](CCC4=CC(=O)CC[C@]34C)[C@@H]1CC[C@]2(O)C(=O)COC(=O)CCC(O)=O
Mol. weight
480.5231 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 9alpha-fluorocortisol
  • 9alpha-fluorocortisol
  • 9 alpha-fluorocortisol acetate
  • alflorone acetate
  • alflorone acetate
  • alflorone acetate
  • alflorone acetate
  • alflorone acetate
  • alflorone acetate
  • astonin
  • astonin
  • cortineff
  • florinef
  • florinef
  • florinef
  • florinef
  • florinef acetate
  • fludrocortison
  • fludrocortison
  • fludrocortisona
  • fludrocortisona
  • fludrocortisone
  • fludrocortisone
  • fludrocortisone
  • fludrocortisone
  • fludrocortisone
  • fludrocortisone
  • fludrocortisone 21-acetate
  • fludrocortisone 21-acetate
  • fludrocortisone acetate
  • fludrocortisone acetate
  • fludrocortisone acetate
  • fludrocortisone acetate
  • fludrocortisone acetate
  • fludrocortisone acetate
  • fludrocortisone acetate
  • fludrocortisonum
  • fludrocortisonum
  • fludrocortone
  • fludrocortone
  • fluohydrocortisone
  • fluohydrocortisone
  • fluorhydrocortisone acetate
  • fluorhydrocortisone acetate
  • fluorocortisol acetate
  • fluorocortisol acetate
  • fluorohydrocortisone acetate
  • panotile

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07037043Phase 3Aug 31, 2025Rouen Normandy University, University of Lille, University of Picardie Jules Verne
NCT06860243Phase 1Apr 11, 2025Merck
NCT06814132Phase 1Mar 14, 2025Merck
NCT06832566Phase 4Feb 15, 2025Hopital La Rabta
NCT06633419Phase 1Jan 2, 2025Merck
NCT06409364Phase 2Nov 1, 2024Griffith University, Monash University, Prince of Wales Hospital, Royal Hobart Hospital, TAS, Australia, Townsville University Hospital, University of Auckland, University of New South Wales, University of Sydney
NCT06566989Phase 1Sep 19, 2024Merck, Orion Corporation
NCT06554639Phase 1Jul 11, 2024Merck
NCT06649409Phase 1Jun 17, 2024Nuvisan Pharma Services, Santhera
NCT06353386Phase 1/Phase 2 (Phase 2)May 20, 2024Merck, Orion Corporation
NCT06136598Phase 1Dec 25, 2023Merck
NCT06136624Phase 3Dec 22, 2023Merck, Orion Corporation
NCT06136650Phase 3Dec 18, 2023Merck, Orion Corporation
NCT06104449Phase 1Nov 14, 2023Merck
NCT05440851N/AApr 30, 2023McMaster University, Queen's University, Belfast, Unity Health Toronto, University of Toronto
NCT05310253N/AFeb 1, 2022Humboldt University
NCT05453214Phase 3Dec 4, 2021Ain Shams University, Al Azhar University
NCT05001854Phase 2/Phase 3 (Phase 3)Aug 31, 2021H.A.C. PHARMA, University of Rennes
NCT04404400Phase 3Jan 31, 2021Assistance Publique - Hôpitaux de Paris, Hôpital Raymond Poincaré
NCT04595942Phase 3Nov 19, 2020Ahvaz Jundishapur University of Medical Sciences, AJA University of Medical Sciences, Imam Khomeini Hospital, Isfahan University, Mahidol University, Rajaie Cardiovascular Medical and Research Center, Shahid Beheshti University of Medical Sciences, Tehran University of Medical Science, University of Tehran, Urmia University of Medical Sciences
Showing 20 of 46 trials
Page 1 / 3

Organizations

Research & Development (66)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit101032023
Orion CorporationFor profit4032023
University of RennesAcademic/Hospital4422008
Humboldt UniversityAcademic/Hospital3312015
University of ParisAcademic/Hospital3122006
H.A.C. PHARMAFor profit2122019
University of New South WalesAcademic/Hospital2212020
University of SydneyAcademic/Hospital2012020
University of VersaillesAcademic/Hospital2212006
Ahvaz Jundishapur University of Medical SciencesAcademic/Hospital1012020
Ain Shams UniversityAcademic/Hospital1112021
AJA University of Medical SciencesAcademic/Hospital1012020
Al Azhar UniversityAcademic/Hospital1012021
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112021
AstraZenecaFor profit1112015
Bristol-Myers SquibbFor profit1112008
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012005
Children's Hospital Los AngelesAcademic/Hospital1012019
CHU AMBROISE PAREAcademic/Hospital1112019
Department of Veteran AffairsGovernment1112005
66 organizations
Page 1 / 4

Marketing (11)

OrganizationOrg typeRelationshipDate
Ani PharmaceuticalsFor profitMKTGMay 31, 2022
Barr LaboratoriesFor profitMKTGJan 21, 2003
Casper Pharma LLCFor profitNDA2Aug 18, 1955
Casper Pharma LLCFor profitNDAAug 18, 1955
Chartwell PharmaceuticalsFor profitMKTGOct 27, 2022
HIBROW HLTHCAREFor profitMKTGFeb 10, 2026
HikmaFor profitMKTGJul 22, 2011
HikmaFor profitSYNOct 27, 2022
Impax LaboratoriesFor profitMKTGMar 18, 2002
Novitium PharmaFor profitMKTGMay 31, 2022
Zydus Discovery DMCCFor profitMKTGOct 16, 2024