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 12 indications[4].[1]

Rogaine is one of 194 small molecule programs targeting Alopecia. It is currently in Approved.

Indications

Total Trials

Active Trials

193

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AlopeciaActive, not recruiting

Anal FissureActive, not recruiting

Cicatricial AlopeciaActive, not recruiting

Williams SyndromeApproved

AcneApproved

Androgenetic AlopeciaApproved

HypertensionActive, not recruiting

Breast CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Alopecia AreataActive, not recruiting

AlopeciaPhase 1

Active, not recruiting

Anal FissurePreclinical

Active, not recruiting

Cicatricial AlopeciaApproved

Active, not recruiting

Williams SyndromeApproved

Approved

AcneApproved

Approved

Androgenetic AlopeciaApproved

Approved

HypertensionApproved

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Alopecia AreataPhase 1

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Rogaine

Pfizer

Approved

1 2

Halaven

Eisai

Preclinical

38 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 5

Lexiscan

Astellas

Preclinical

1 6

Adenocard

Astellas

Preclinical

1 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Zinecard

CChildren's Oncology Group

Preclinical

2 9

Chirocaine

PPurdue Pharma LP

Preclinical

1 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Cicatricial Alopecia

NCT04207931

Q1 2027

Phase 2Active, not recruiting

Hair Loss

NCT05778825

Q2 2027

N/ARecruiting

Alopecia

NCT07373054

Q3 2027

Phase 1Recruiting

Breast Reconstruction

NCT07264790

Clinical

Trials by Indication[1]

Androgenetic Alopecia11 trials

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

Hair Regeneration in Androgenetic Alopecia

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

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

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 in Androgenetic Alopecia in Females

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

Various Procedural Treatment Options for Androgenetic Alopecia

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

Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia

Not yet recruiting·IIndustrial Farmacéutica Cantabria, S.A.·Phase 3·NCT05888922·520 enrolled

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

Completed·—·Phase 3·NCT00958750·113 enrolled

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

Unknown status·—·Phase 4·NCT04293822·60 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

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

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

Female Pattern Hair Loss2 trials

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

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

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

Alopecia2 trials

Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia

Recruiting·FFujian Medical University Union Hospital·N/A·NCT07373054·18 enrolled

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

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

Anal fissure1 trial

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

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

10 more indications

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

Children1 trial

Efficacy of Minoxidil in Children With Williams-Beuren Syndrome

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

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

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

Clinical Trial1 trial

Bioavailability Clinical Trial of Oral Minoxidil 1 mg

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

Efficacy1 trial

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Recruiting·SSamson Clinical Operations Pty Ltd·Phase 3·NCT06924632·132 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 — 28 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

Q3 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Androgenetic Alopecia11 trials

Female Pattern Hair Loss2 trials

Alopecia2 trials

Alopecia Areata2 trials

Anal fissure1 trial

Effectiveness1 trial

Children1 trial

Breast Cancer1 trial

Hypertension1 trial

Cicatricial Alopecia1 trial

Hair Loss1 trial

Clinical Trial1 trial

Ovarian Cancer1 trial

Efficacy1 trial

Breast Reconstruction1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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