Rogaine

(Minoxidil)

ApprovedSmall molecule

Minoxidil is used to treat hair loss and promote hair growth on the scalp. It's also used to treat high blood pressure when taken as a tablet.[2] Rogaine is currently approved and in use across 13 indications[4].[1]

Rogaine is one of 180 small molecule programs targeting Hypotrichosis. It is currently in Approved.

Indications

Total Trials

Active Trials

179

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HypotrichosisActive, not recruiting

HypertensionActive, not recruiting

Williams SyndromeApproved

AcneApproved

Anal FissureActive, not recruiting

Breast ReconstructionRecruiting

Cicatricial AlopeciaActive, not recruiting

Anatomic Stage I Breast Cancer AJCC V8Not yet recruiting

EfficacyRecruiting

AlopeciaActive, not recruiting

HypotrichosisApproved

Active, not recruiting

HypertensionApproved

Active, not recruiting

Williams SyndromeApproved

Approved

AcneApproved

Approved

Anal FissurePreclinical

Active, not recruiting

Breast ReconstructionPhase 1

Recruiting

Cicatricial AlopeciaApproved

Active, not recruiting

Anatomic Stage I Breast Cancer AJCC V8Phase 2

Not yet recruiting

EfficacyPhase 3

Recruiting

AlopeciaPhase 1

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Rogaine

Pfizer

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Androgenetic Alopecia

NCT05888922

Q1 2027

Phase 2Active, not recruiting

Hair Loss

NCT05778825

Q3 2027

Phase 1Recruiting

Breast Reconstruction

NCT07264790

Q4 2027

Phase 1Recruiting

Breast Cancer

NCT05417308

Phase 2Not yet recruiting

Anatomic Stage I Breast Cancer AJCC V8

NCT07594678

Clinical

Trials by Indication[1]

Androgenetic Alopecia11 trials

Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia

Not yet recruiting·SSheikh Zayed Federal Postgraduate Medical Institute·Phase 3·NCT07273799·200 enrolled

Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia

Unknown status·AAneira Pharma, Inc.·Phase 1·NCT05864885·14 enrolled

Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia

Unknown status·IIndonesia University·Phase 2/3·NCT05990400·40 enrolled

Show 8 more trials

Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients

Unknown status·—·Phase 3·NCT01655108·60 enrolled

Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia

Unknown status·—·Phase 4·NCT04293822·60 enrolled

Various Procedural Treatment Options for Androgenetic Alopecia

Not yet recruiting·SSheikh Zayed Medical College·Phase 2·NCT06826001·190 enrolled

Topical Cetirizine in Androgenetic Alopecia in Females

Completed·—·Phase 2/3·NCT04481412·66 enrolled

Hair Regeneration in Androgenetic Alopecia

Unknown status·DDr. dr. Lili Legiawati, SpKK(K)·N/A·NCT06066827·60 enrolled

Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia

Completed·—·Phase 3·NCT00958750·113 enrolled

Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Completed·NNatalie GARCIA BARTELS·Phase 2·NCT01319370·70 enrolled

International Phase III, Multi Center, Randomized, Double Blind, Placebo and Active Controlled and Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female Patients With Androgenetic Alopecia

Active, not recruiting·IIndustrial Farmacéutica Cantabria, S.A.·Phase 3·NCT05888922·520 enrolled

Alopecia Areata2 trials

Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata

Unknown status·—·N/A·NCT05587257·60 enrolled

A Novel Formulation of Sildenafil-loaded Nanocarriers for Treatment of Alopecia Areata

Completed·—·Phase 1·NCT06527729·28 enrolled

Female Pattern Hair Loss2 trials

Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss

Recruiting·SSohag University·Phase 1/2·NCT06333600·45 enrolled

Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss

Completed·UUniversity of British Columbia·Phase 2·NCT00175617·40 enrolled

Children1 trial

Efficacy of Minoxidil in Children With Williams-Beuren Syndrome

Completed·HHospices Civils de Lyon·Phase 2·NCT00876200·21 enrolled

Anal fissure1 trial

Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure

Completed·MMansoura University·N/A·NCT03528772·62 enrolled

12 more indications

Hypertension1 trial

Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

Terminated·UUniversity of Chicago·N/A·NCT00607477·2 enrolled

Cicatricial Alopecia1 trial

Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study

Recruiting·WWake Forest University Health Sciences·Phase 4·NCT04207931·250 enrolled

Breast Cancer1 trial

Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 1·NCT05417308·50 enrolled

Efficacy1 trial

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Recruiting·SSamson Clinical Operations Pty Ltd·Phase 3·NCT06924632·132 enrolled

Alopecia1 trial

Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

Active, not recruiting·NNorthwestern University·Phase 1·NCT03831334·14 enrolled

Ovarian Cancer1 trial

Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer

Unknown status·LLoyola University·Phase 2·NCT05272462·34 enrolled

Clinical Trial1 trial

Bioavailability Clinical Trial of Oral Minoxidil 1 mg

Completed·IIndustrial Farmacéutica Cantabria, S.A.·Phase 1·NCT06015516·14 enrolled

Hair Loss1 trial

A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05778825·10 enrolled

Effectiveness1 trial

A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 3·NCT00151515·352 enrolled

Anatomic Stage I Breast Cancer AJCC v81 trial

A Pilot Study of Low-Level Red-Light Therapy Combined With Topical Minoxidil Compared With Topical Minoxidil Alone in Breast Cancer Patients With Chemotherapy-Induced Alopecia

Not yet recruiting·OOhio State University Comprehensive Cancer Center·Phase 2·NCT07594678·50 enrolled

Androgenic Alopecia1 trial

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia: A Prospective, Randomized, Controlled Clinical Trial

Completed·FFujian Medical University Union Hospital·Preclinical·NCT07373054·18 enrolled

Breast Reconstruction1 trial

Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction

Recruiting·DDuke University·Phase 1·NCT07264790·25 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

LONITEN

NDA NDA018154

Feb 9, 1996

ROGAINE (FOR MEN)

NDA NDA019501

Nov 14, 1997

ROGAINE EXTRA STRENGTH (FOR MEN)

NDA NDA020834

Jan 20, 2006

MEN'S ROGAINE

NDA NDA021812

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Minoxidil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rogaine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Minoxidil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Minoxidil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021812). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sulfonylurea Receptor 2, Kir6.2 Opener[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Rogaine

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Androgenetic Alopecia11 trials

Alopecia Areata2 trials

Female Pattern Hair Loss2 trials

Children1 trial

Anal fissure1 trial

Hypertension1 trial

Cicatricial Alopecia1 trial

Breast Cancer1 trial

Efficacy1 trial

Alopecia1 trial

Ovarian Cancer1 trial

Clinical Trial1 trial

Hair Loss1 trial

Effectiveness1 trial

Anatomic Stage I Breast Cancer AJCC v81 trial

Androgenic Alopecia1 trial

Breast Reconstruction1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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