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eflornithine

Trade name: ornidyl

Small moleculeapprovedOrphan Drug FDA

Approved

Nov 28, 1990

Eflornithine is a prescription drug indicated in the treatment of facial hirsutism (excessive hair growth). Eflornithine hydrochloride cream for topical application is intended for use in women suffering from facial hirsutism and is sold by Allergan, Inc. under the brand name Vaniqa. Besides being a non-mechanical and non-cosmetic treatment, eflornithine is the only non-hormonal and non-systemic prescription option available for women who suffer from facial hirsutism. Eflornithine for injection against sleeping sickness was manufactured by Sanofi Aventis and sold under the brand name Ornidyl in the USA. It is now discontinued. Eflornithine is on the World Health Organization's List of Essential Medicines. Eflornithine prevents hair growth by inhibiting the anagen phase of hair production. This occurs by eflornithine irreversibly binding (also called suicide inhibition) to ornithine decarboxylase (ODC) and physically preventing the natural substrate ornithine from accessing the active site. — NCATS

Clinical trial activity

44 trials · 46 clinical orgs · 4 marketing orgs

Phase 1
7
Phase 2
30
Phase 3
11
Phase 4
5

Earliest trial started Oct 1, 1995 (NCT00003076)

Timeline

1980s

  1. Apr 23, 1986

    Orphan Drug Designation

1990s

  1. Nov 28, 1990

    Sanofi-Aventis — Earliest FDA Approval

  2. Nov 28, 1990

    Sanofi-Aventis — NDA Organization

  3. Nov 28, 1990

    Sanofi-Aventis — NDA Secondary Org

  4. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jul 27, 2000

    Skinmedica — NDA Secondary Org

  2. Jul 27, 2000

    AbbVie — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Dec 13, 2023

    US WorldMeds — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 28, 1990

Chemistry & pharmacology

Loading structure…

SMILES

NCCCC(N)(C(=O)O)C(F)F
Mol. weight
182.17 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 2-(difluoromethyl)ornithine
  • 2-(difluoromethyl)ornithine
  • alpha-(difluoromethyl)-dl-ornithine
  • alpha-difluoromethylornithine
  • alpha-difluoromethylornithine
  • alpha-difluoromethylornithine
  • dfmo
  • dfmo
  • dfmo hcl
  • dfmo hcl
  • difluoromethylornithine
  • difluoromethylornithine
  • difluromethylornithine
  • difluromethylornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine
  • eflornithine hcl
  • eflornithine hcl
  • eflornithine hcl
  • eflornithine hcl
  • eflornithine hdyrochloride
  • eflornithine hydrochloride
  • eflornithine hydrochloride
  • eflornithine hydrochloride
  • eflornithine hydrochloride anhydrous
  • eflornithine hydrochloride hydrate
  • eflornithine hydrochloride hydrate
  • eflornithine hydrochloride hydrate
  • eflornithine hydrochloride monohydrate
  • eflornithine hydrochloride monohydrate
  • eflornithine hydrochloride monohydrate
  • eflornithine hydrochloride monohydrate
  • eflornithine hydrochloride monohydrate
  • eflornithine hydrochloride monohydrate
  • elfornithine
  • mdl-71782a
  • mdl-71782a
  • ornidyl
  • ornidyl
  • ornidyl
  • ornidyl
  • (rs)-2,5-diamino-2-(difluoromethyl)pentanoic acid
  • (rs)-2,5-diamino-2-(difluoromethyl)pentanoic acid
  • vaniqa
  • vaniqa
  • vaniqa
  • α-difluoromethylornithine
  • α-difluoromethylornithine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06976424Phase 4Jul 15, 2025Khyber Medical University Peshawer
NCT06465199Phase 1/Phase 2 (Phase 2)Dec 1, 2024Aminex Therapeutics, Inc., Pennsylvania State University
NCT05717153Early Phase 1 (Phase 1)Aug 28, 2023Mayo Clinic, National Cancer Institute (NCI)
NCT06957834Phase 2Jun 6, 2023Government of Singapore
NCT04403282Phase 4Jul 31, 2020United States Army
NCT04301843Phase 2Jun 1, 2020Beat Childhood Cancer, Beat NB Cancer Foundation, KC Pharma, The Spectrum Health Group
NCT04091022Phase 2Dec 1, 2019National Cancer Institute (NCI), National Institutes of Health (NIH), University of Alabama, Birmingham
NCT03794349Phase 2May 28, 2019National Cancer Institute (NCI)
NCT02794428Phase 2Sep 19, 2016Cancer Prevention Pharmaceuticals, Inc., National Cancer Institute (NCI), Vanderbilt University
NCT02796261Phase 3Jul 1, 2016Orbus Therapeutics, Inc.
NCT02636569N/AFeb 1, 2016University of Alabama, Birmingham
NCT02679144Phase 2Feb 1, 2016Beat NB Cancer Foundation, Because of Ezra, KC Pharma, The Spectrum Health Group
NCT02559778Phase 1Sep 1, 2015Beat NB Cancer Foundation, Because of Ezra, Dell, The Spectrum Health Group
NCT02384889Phase 1Apr 1, 2015Indiana University
NCT02395666Phase 2Mar 1, 2015Beat NB Cancer Foundation, Because of Ezra, The Spectrum Health Group
NCT02139397Phase 1/Phase 2 (Phase 2)May 1, 2014Beat NB Cancer Foundation, Because of Ezra, The Spectrum Health Group, University of Kansas
NCT01636128Phase 2Mar 1, 2014Cancer Prevention Pharmaceuticals, Inc., University of Arizona
NCT02030964Phase 1Dec 1, 2013National Cancer Institute (NCI), University of Pennsylvania
NCT01483144Phase 3Oct 1, 2013Cancer Prevention Pharmaceuticals, Inc., University of Hamburg, University of Rochester
NCT01349881Phase 3Mar 1, 2013Cancer Prevention Pharmaceuticals, Inc., National Cancer Institute (NCI), Southwest Oncology Group, University of California, Irvine
Showing 20 of 44 trials
Page 1 / 3

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government17631995
The Spectrum Health GroupAcademic/Hospital8832010
Cancer Prevention Pharmaceuticals, Inc.For profit7332010
Beat NB Cancer FoundationAcademic/Hospital6022012
University of ArizonaAcademic/Hospital5222001
Because of EzraAcademic/Hospital4022014
Drugs for Neglected Diseases InitiativeAcademic/Hospital3322005
EpicentreFor profit3212001
KC PharmaFor profit3022016
Medecins Sans FrontieresAcademic/Hospital3012001
University of Alabama, BirminghamAcademic/Hospital3322001
University of California, IrvineAcademic/Hospital3121998
Mayo ClinicAcademic/Hospital2122009
University of BaselAcademic/Hospital2022005
University of HawaiiAcademic/Hospital2022010
University of Texas at HoustonAcademic/Hospital2112000
University of WisconsinAcademic/Hospital2222000
Aminex Therapeutics, Inc.For profit1012024
Beat Childhood CancerAcademic/Hospital1012020
Chao Family Comprehensive Cancer CenterAcademic/Hospital1011998
46 organizations
Page 1 / 3

Marketing (5)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJul 27, 2000
Sanofi-AventisFor profitNDANov 28, 1990
Sanofi-AventisFor profitNDA2Nov 28, 1990
SkinmedicaFor profitNDA2Jul 27, 2000
US WorldMedsFor profitMKTGDec 13, 2023