minoxidil

Trade name: loniten

Small moleculeapproved

Approved

Oct 18, 1979

Minoxidil is an orally effective direct acting peripheral vasodilator that reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance. Minoxidil is also used topically to treat androgenetic alopecia. Microcirculatory blood flow in animals is enhanced or maintained in all systemic vascular beds. In man, forearm and renal vascular resistance decline; forearm blood flow increases while renal blood flow and glomerular filtration rate are preserved. The predominant site of minoxidil action is arterial. Venodilation does not occur with minoxidil; thus, postural hypotension is unusual with its administration. The antihypertensive activity of minoxidil is due to its sulphate metabolite, minoxidil sulfate. Minoxidil is thought to promote the survival of human dermal papillary cells (DPCs) or hair cells by activating both extracellular signal-regulated kinase (ERK) and Akt and by preventing cell death by increasing the ratio of BCl-2/Bax. Minoxidil may stimulate the growth of human hairs by prolonging anagen through these proliferative and anti-apoptotic effects on DPCs. Minoxidil, when used as a vasodilator, acts by opening adenosine triphosphate-sensitive potassium channels in vascular smooth muscle cells. This vasodilation may also improve the viability of hair cells or hair follicles. Minoxidil is used for the treatment of severe hypertension and in the topical treatment (regrowth) of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia. — NCATS

Clinical trial activity

84 trials · 89 clinical orgs · 28 marketing orgs

Phase 1
18
Phase 2
43
Phase 3
21
Phase 4
12

Earliest trial started Oct 1, 2003 (NCT00151515)

Timeline

1970s

  1. Oct 18, 1979

    Earliest FDA Approval

  2. Oct 18, 1979

    Pharmacia & Upjohn — NDA Secondary Org

  3. Oct 18, 1979

    Pfizer — Marketing Organization

  4. Oct 18, 1979

    Pfizer — NDA Secondary Org

1980s

  1. Mar 3, 1987

    Watson Pharmaceuticals — Marketing Organization

  2. Jul 15, 1988

    Quantum Pharmaceutical — Marketing Organization

  3. Aug 17, 1988

    Johnson and Johnson — NDA Secondary Org

  4. Nov 14, 1988

    Par Pharmaceuticals — Marketing Organization

  5. Nov 14, 1988

    Endo Pharmaceuticals — Marketing Organization

1990s

  1. Dec 13, 1995

    Sun Pharmaceuticals — Marketing Organization

  2. Dec 14, 1995

    Mutual Pharmaceutical — Marketing Organization

  3. Apr 5, 1996

    P&L Development — Marketing Organization

  4. Apr 5, 1996

    Actavis — Marketing Organization

  5. Apr 5, 1996

    Teva — Marketing Organization

  6. Apr 9, 1996

    Bausch & Lomb — Marketing Organization

  7. May 23, 1996

    Copley Pharmaceuticals — Marketing Organization

  8. Oct 18, 1996

    Sight Pharms — Marketing Organization

  9. Dec 24, 1996

    Hi Tech Pharmaceuticals — Marketing Organization

  10. Dec 24, 1996

    Akorn, Inc. — Marketing Organization

  11. Dec 24, 1996

    Hikma — Marketing Organization

  12. Feb 28, 1997

    Wockhardt — Marketing Organization

  13. Feb 28, 1997

    Aurobindo Pharma — Marketing Organization

  14. Apr 29, 1998

    Apotex — Marketing Organization

  15. Jul 30, 1999

    Perrigo — Marketing Organization

2000s

  1. Nov 17, 2000

    Avacor Prods — Marketing Organization

  2. Jan 1, 2003

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

  3. Aug 24, 2004

    Ei Inc — Marketing Organization

  4. Aug 24, 2004

    PURE SOURCE — Marketing Organization

  5. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  2. Dec 31, 2018

    Taro Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewOct 18, 1979

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=CC(N)=[N+]1[O-])N2CCCCC2
Mol. weight
209.2483 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Over the Counter

Oral

Yes

Parenteral

No

Topical

Yes

Black box warningProdrug

Sources

Also known as

  • 2,4-diamino-6-piperidinopyrimidine 3-oxide
  • 2,4-diamino-6-piperidinopyrimidine 3-oxide
  • 6-piperidin-1-ylpyrimidine-2,4-diamine 3-oxide
  • 6-piperidin-1-ylpyrimidine-2,4-diamine 3-oxide
  • alostil
  • alostil
  • apo-gain
  • apo-gain
  • loniten
  • loniten
  • loniten
  • loniten
  • lonolox
  • lonolox
  • lonolox
  • men's rogaine
  • men's rogaine
  • minodyl
  • minodyl
  • minossidile
  • minossidile
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil
  • minoxidil extra strength
  • minoxidilum
  • minoxidilum
  • minoximen
  • minoximen
  • normoxidil
  • normoxidil
  • regaine
  • regaine
  • regaine for men
  • regaine for women
  • rogaine
  • rogaine
  • rogaine
  • rogaine extra strength
  • sm04554
  • theroxidil
  • theroxidil
  • tricoxidil
  • tricoxidil
  • u-10858
  • u-10858

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07264790Phase 1Dec 31, 2025Duke University
NCT07273799Phase 3Dec 20, 2025Sheikh Zayed Medical College
NCT07203599Phase 1/Phase 2 (Phase 2)Sep 20, 2025Shenzhen University
NCT06924632Phase 3Jul 14, 2025Samson Clinical Operations Pty Ltd
NCT07056933N/AJul 8, 2025Cairo University
NCT07012486Early Phase 1 (Phase 1)Jun 30, 2025Fudan University
NCT07018349N/AJun 15, 2025Jinnah Postgraduate Medical Centre
NCT07011485Phase 2May 14, 2025PDFE Pharma Innovations FZCO
NCT06826001Phase 2Feb 28, 2025Sheikh Zayed Medical College
NCT07080931Phase 3Feb 24, 2025Sunshine Lake Pharma Co., Ltd.
NCT06813963Phase 4Feb 15, 2025Southern Medical University
NCT06501924Phase 3Jan 15, 2025Applied Biology, Inc., Daniel Alain, Inc., Follea International Limited, University of Roma La Sapienza
NCT07076706Phase 2Dec 5, 2024Government of China, Peking University
NCT06679556Phase 1Nov 6, 2024Samson Clinical Operations Pty Ltd
NCT06590779N/ANov 2, 2024Cosmetique Active International, University of Nice Sophia Antipolis, University of Paris
NCT06484881Phase 3Sep 15, 2024Applied Biology, Inc., Follea International Limited, University of Roma La Sapienza
NCT06556056N/AJun 30, 2024NovoBliss Research Pvt Ltd
NCT05888922Phase 3Mar 31, 2024BioClever 2005 S.L., Bioskin GmbH, Industrial Farmaceutica Cantabria, Spain
NCT07038941Phase 1Mar 19, 2024Government of China, Peking University
NCT06015516Phase 1Feb 29, 2024Industrial Farmaceutica Cantabria, Spain
Showing 20 of 84 trials
Page 1 / 5

Organizations

Research & Development (89)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mae Fah Luang University HospitalAcademic/Hospital5522011
University of IndonesiaAcademic/Hospital5532021
Johnson and JohnsonFor profit4322003
Applied Biology, Inc.For profit3322016
Assiut UniversityAcademic/Hospital3332020
Biosplice TherapeuticsFor profit3322014
Cairo UniversityAcademic/Hospital3332016
University of Roma La SapienzaAcademic/Hospital3022016
AllerganFor profit2212011
Aneira Pharma, Inc.For profit2212023
Follea International LimitedFor profit2012024
GaldermaFor profit2212015
Government of ChinaGovernment2222024
Humboldt UniversityAcademic/Hospital2222008
Industrial Farmaceutica Cantabria, SpainFor profit2222024
Mayo ClinicAcademic/Hospital2122006
MFL University Hospital, BangkokAcademic/Hospital2012012
Peking UniversityAcademic/Hospital2022024
PT. Kimia Farma (Persero) TbkFor profit2022021
Samson Clinical Operations Pty LtdFor profit2222024
89 organizations
Page 1 / 5

Marketing (36)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGApr 5, 1996
Akorn, Inc.For profitMKTGDec 24, 1996
ApotexFor profitMKTGApr 29, 1998
Aurobindo PharmaFor profitSYNApr 22, 2024
Aurobindo PharmaFor profitMKTGFeb 28, 1997
Avacor ProdsFor profitMKTGNov 17, 2000
Bausch & LombFor profitMKTGApr 9, 1996
Copley PharmaceuticalsFor profitMKTGMay 23, 1996
Ei IncFor profitMKTGAug 24, 2004
Endo PharmaceuticalsFor profitMKTGNov 14, 1988
Hi Tech PharmaceuticalsFor profitMKTGDec 24, 1996
HikmaFor profitMKTGDec 24, 1996
Johnson and JohnsonFor profitNDA2Aug 17, 1988
Mutual PharmaceuticalFor profitMKTGDec 14, 1995
P&L DevelopmentFor profitMKTGApr 5, 1996
PURE SOURCEFor profitMKTGAug 24, 2004
Par PharmaceuticalsFor profitMKTGNov 14, 1988
PerrigoFor profitMKTGJul 30, 1999
PerrigoFor profitSYNJun 13, 2001
PerrigoFor profitSYNApr 28, 2011
PerrigoFor profitSYNMar 15, 2002
PerrigoFor profitSYNApr 28, 2011
PfizerFor profitMKTGOct 18, 1979
PfizerFor profitNDA2Oct 18, 1979
Pharmacia & UpjohnFor profitNDA2Oct 18, 1979
Quantum PharmaceuticalFor profitMKTGJul 15, 1988
Sight PharmsFor profitMKTGOct 18, 1996
Sun PharmaceuticalsFor profitMKTGDec 13, 1995
Taro PharmaceuticalsFor profitSYNDec 31, 2018
Taro PharmaceuticalsFor profitMKTGDec 31, 2018
TevaFor profitMKTGApr 5, 1996
UpjohnFor profitNDA
Upsher-Smith LaboratoriesFor profitMKTG
Watson PharmaceuticalsFor profitMKTGMar 3, 1987
Watson PharmaceuticalsFor profitSYNFeb 17, 2017
WockhardtFor profitMKTGFeb 28, 1997