FDA issued a warning in April 2025 about compounded topical finasteride, citing 32 reported adverse-event cases (including low libido and erectile dysfunction) between 2019-2024.
- Lab
- Phase 1
- Phase 2
- Phase 3
- Approved
Approved (some countries)
How it works
5-alpha-reductase inhibitor applied directly to the scalp to lower local DHT with the goal of less systemic absorption/side effects than oral finasteride.
Results so far
No pivotal US trial data cited; European standardized formulations have 'substantial randomized clinical trial evidence' per secondary sources, but no specific numeric result was verified in this research pass.
What's next
No FDA approval timeline exists because no sponsor has an active NDA for topical finasteride identified in this research.
In India
Not specifically assessed for CDSCO status; topical finasteride is informally available via some Indian compounding/telehealth channels but this was not independently verified in this research pass.
Sources
- News report ↗ (accessed 2026-10-17)
- Journal paper ↗ (accessed 2026-10-17)
- Journal paper ↗ (accessed 2026-10-17)
What to do today: treatments in development aren't a reason to wait. Ask a dermatologist about the options that work now, such as minoxidil and, for men, finasteride.
Discussion
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