Phase 2Pattern hair loss

HMI-115

DraftReviewed by the HairLoss99 editorial team · checked 17 Oct 2026

Hope Medicine received US FDA clearance to begin a Phase 2 trial (180 participants, HMI-115 vs placebo over 24 weeks) after positive Phase 1b results.

How it works

Monoclonal antibody against the prolactin receptor (PRLR); blocking PRLR signalling is hypothesized to relieve prolactin-driven suppression of hair follicles.

Developer
Hope Medicine (Nanjing) / originally Bayer (as BAY-1158061)
Stage
Phase 1b completed; Phase 2 ongoing (FDA clearance obtained, 180-participant trial)
Evidence so far
Company or news reports only · limited information

Results so far

Phase 1b: average non-vellus target area hair count increased by 14 hairs/cm2 from baseline in two male patients; drug reported safe and well tolerated. Note the very small n reported in the search summary.

What's next

Phase 2 enrollment underway as of research date; no Phase 3/filing timeline publicly stated.

In India

No India-specific development identified.

Sources

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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