Bimatoprost
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Bimatoprost: From Glaucoma / Ocular Hypertension to Alopecia
One-Sentence Summary
Bimatoprost is a prostamide/PGF2-alpha analog originally approved for ocular hypertension and open-angle glaucoma. The TxGNN model predicts it may be effective for alopecia, with 11 clinical trials (including two completed Phase 2 RCTs of about 300 patients each) and 20 publications supporting this direction.
Note on indication choice: TxGNN’s top-ranked prediction is “malformation syndrome with odontal and/or periodontal component”. That prediction has no supporting evidence (see the next section), so this report leads with alopecia, the best-supported of the 10 predicted indications.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Glaucoma / ocular hypertension (taken from the literature, because the license records carry no indication text) |
| Predicted New Indication | Alopecia |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L2 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 licenses in total (NDA and ANDA) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available from DrugBank. From the literature and the drug’s class, bimatoprost is a prostamide/PGF2-alpha analog that acts on FP receptors. In the hair follicle it prolongs the anagen (growth) phase and stimulates growth. Eyelash lengthening was first noticed as a side effect in glaucoma patients, and bimatoprost 0.03% is now FDA-approved for thickening thin eyelashes.
This is a mechanism-based link rather than a disease-based one. Scalp, eyebrow and eyelash hair loss share the same follicle biology, so the anagen-prolonging effect is plausible for scalp hair loss. That includes androgenetic alopecia and, more tentatively, alopecia areata and chemotherapy-induced hair loss. In alopecia areata the underlying autoimmune process is not addressed by this mechanism.
The other nine predictions vary widely in support. All ten scores are about 0.9995–0.99997, so the score does not separate strong from weak candidates.
- No plausible link (Hold): periodontal malformation syndrome (rank 1, whose 20 retrieved papers are about periodontitis and do not mention bimatoprost), Dandy-Walker malformation syndrome, and pulmonary arteriovenous malformation.
- Directionally inconsistent (Hold): Ambras hypertrichosis, a hair-excess condition, where bimatoprost promotes hair growth.
- Partially plausible but without disease-specific evidence (Hold): hypotrichosis simplex of the scalp, congenital hypotrichosis milia, diffuse alopecia areata, and isolated genetic hair shaft abnormality.
- Mechanism and case-report support only: genetic alopecia, which has no trials of its own. It is a “Research Question” that relies on the alopecia evidence below.
Clinical Trial Evidence
Results are not included in the supplied data, so the findings below are the trial designs and aims. Effect sizes are unverified.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01325350 | Phase 2 | Completed | 306 | Double-blind RCT: 3 doses of bimatoprost solution vs vehicle and OTC minoxidil 2% in women with female pattern hair loss |
| NCT01325337 | Phase 2 | Completed | 307 | Double-blind RCT: 3 doses of bimatoprost vs vehicle and OTC minoxidil 5% in men with androgenic alopecia |
| NCT01904721 | Phase 2 | Completed | 244 | Safety and efficacy study of bimatoprost in men with androgenic alopecia |
| NCT02170662 | Phase 2 | Completed | 33 | Effect of topical bimatoprost 0.03% on scalp hair growth (androgen-dependent follicles) |
| NCT05600673 | Phase 1/2 | Completed | 30 | CO2 fractional laser plus bimatoprost 0.03% in alopecia areata |
| NCT01023841 | Phase 4 | Completed | 71 | Bimatoprost 0.03% vs vehicle for eyelash loss or hypotrichosis in children |
| NCT01189279 | Phase 1 | Completed | 42 | Safety, tolerability and PK of new bimatoprost formulations in alopecia patients |
| NCT02848300 | Phase 1 | Completed | 11 | Skin PK and tolerability of two scalp formulations over 14 days in men with androgenetic alopecia |
| NCT02676310 | Phase 1 | Terminated | 53 | Dose-escalation safety and PK study in men with androgenetic alopecia (reason for termination not provided) |
| NCT00187577 | N/A | Completed | 14 | Latanoprost vs bimatoprost for eyelash growth in alopecia areata (very small, different site) |
One further trial (NCT00999557, eyebrow/eyelash regrowth after chemotherapy) was withdrawn with 0 participants and is not listed.
Literature Evidence
Two tier-1 or tier-2 items, PMID 32250713 and 40252129, have results that are not in the supplied abstract excerpts.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 32250713 | 2022 | Systematic review / network meta-analysis | J Dermatol Treat | Compares the relative efficacy of non-surgical androgenetic alopecia monotherapies in men and women |
| 40252129 | 2025 | Clinical trial | Arch Dermatol Res | Evaluates CO2 fractional laser combined with bimatoprost for hair regrowth in alopecia areata |
| 37089845 | 2023 | Non-randomized open-label trial | Indian Dermatol Online J | Bimatoprost vs clobetasol propionate in scalp alopecia areata |
| 35278027 | 2022 | Prospective open-label study | Dermatol Ther | Ophthalmic bimatoprost on the eyelid margins for at least 12 weeks in eyelash loss from alopecia totalis and universalis |
| 28264599 | 2017 | Review | Expert Opin Investig Drugs | Reviews bimatoprost for eyelash, eyebrow and scalp alopecia, and its FDA approval for eyelashes |
| 29854658 | 2018 | Review | Indian Dermatol Online J | Overview of bimatoprost in dermatology, including alopecia of the eyelashes and eyebrows |
| 35040730 | 2022 | Preclinical | Drug Deliv | Topical formulation with 4.6-fold higher skin flux and in vivo hair regrowth in an androgenic alopecia model |
| 38577618 | 2024 | Preclinical | Int J Pharm X | Spanlastic nanogel for dermal delivery of bimatoprost with hair regrowth efficacy in an androgenic alopecia model |
US Market Information
Showing 5 of 20 licenses. The source records contain no approved-indication text.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA 211911 | DURYSTA (Allergan, Inc.) | Implant | Not provided in source record |
| ANDA 207601 | Bimatoprost (Somerset Therapeutics) | Solution/drops | Not provided in source record |
| ANDA 202719 | Bimatoprost (Sandoz Inc) | Solution/drops | Not provided in source record |
| ANDA 210263 | Bimatoprost (Alembic Pharmaceuticals) | Solution/drops | Not provided in source record |
| ANDA 210126 | Bimatoprost (Fosun Pharma USA) | Solution/drops | Not provided in source record |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Two completed Phase 2 RCTs (about 300 patients each, in men and women with androgenetic alopecia), a pediatric Phase 4 study and several Phase 1 PK studies support clinical feasibility, and the FP-receptor mechanism is biologically plausible. No Phase 3 trial exists, and efficacy results are not in the supplied data. The other nine predictions should stay on Hold.
To proceed, the following is needed:
- Retrieve and confirm the Phase 2 results (NCT01325350, NCT01325337, NCT01904721), especially efficacy versus vehicle and minoxidil.
- Define the target subtype (scalp androgenetic vs alopecia areata vs chemotherapy-induced, or eyelash/eyebrow), since the evidence differs for each.
- Obtain the package insert warnings and contraindications (blocking data gap DG001), and plan monitoring for ocular and periocular safety such as pigmentation and irritation.
- Check why NCT02676310 was terminated.
- Fill the DrugBank mechanism-of-action gap (DG002).
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.