HMI-115: Frequently Asked Questions About Hair Loss Treatment

What is HMI-115?

HMI-115 is an investigational monoclonal antibody directed at prolactin receptor signalling. It is being studied as a treatment for androgenetic alopecia and for endometriosis-associated pain. It is not approved by any regulator for either condition, and it is not available as a medicine. Whether it works for hair loss, and how safe it is over the long term, are open questions that the completed trials have not yet answered in published form.

Who is developing HMI-115?

The antibody is being developed by Hope Medicine, under a licensing arrangement announced with Bayer AG. A licensing deal reflects a company's commercial judgment about a programme; it is not evidence that the drug works.

Which companies are involved in its development?

• Hope Medicine: the biotechnology company developing HMI-115.
• Chime Biologics: the contract manufacturer that Hope Medicine announced a manufacturing agreement with in 2023.
• Bayer AG: the multinational pharmaceutical company named in the 2019 licensing agreement.

How long has HMI-115 been under investigation? A timeline

Before 2019: Preclinical work on prolactin-receptor blockade in hair follicles, including animal studies, predates the Bayer licensing agreement.

2019: Hope Medicine and Bayer announce a licensing agreement covering the antibody.

2021: A Phase 2 study in endometriosis-associated pain begins (NCT05101317, 142 participants, United States / China / Poland).

2022: The Phase 1b hair-loss study begins in Australia (NCT05324293), enrolling 16 participants with androgenetic alopecia over a 24-week treatment period.

2023: A Phase 2 study in Chinese men with androgenetic alopecia begins (NCT06118866, 192 participants). Hope Medicine also announces the manufacturing agreement with Chime Biologics.

2026: A Phase 3 study in endometriosis-associated pain begins recruiting in China (NCT07318688). There is no registered Phase 3 hair-loss study.

Where is HMI-115 being tested?

The registered hair-loss trials have run in Australia (Phase 1b) and China (Phase 2). The endometriosis programme has run in the United States, China and Poland. Trials in more countries indicate an expanding development programme, not a step toward approval; approval depends on the results, which have not been published.

How do the trials work?

The Phase 2 studies are randomized and double-blind, meaning neither participants nor investigators know who receives the drug and who receives placebo. That design is what allows a treatment effect to be separated from expectation and normal variation. The Phase 1b Australian study, by contrast, was a small early-phase safety and tolerability study in 16 people — the kind of study that cannot establish whether a drug works.

Who could participate in the trials?

Entry criteria published on the trial registry for the hair-loss studies have included:

• Adults, broadly in the 18–65 range.
• A diagnosis of androgenetic alopecia.
• Not using other hair loss treatments during the study.
• Willingness to have small areas of hair clipped for hair-count measurement.

Exact criteria differ between studies and change over time; the registry entry for a specific trial is the only reliable source.

How is HMI-115 given in the trials?

In the trials, HMI-115 is given by subcutaneous injection. The Phase 1b study used 240 mg every two weeks over 24 weeks; the Phase 2 study included 120 mg every four weeks, 240 mg every four weeks, and 240 mg every two weeks. These are investigational trial regimens under medical supervision. There is no approved dose of HMI-115, because there is no approved product, and nothing here should be read as a dosing instruction.

Has it received official approvals?

No. HMI-115 has not been approved for marketing by the FDA, the EMA, China's NMPA, or any other regulator, for hair loss or for endometriosis.

What has happened is regulatory clearance to run trials. Clearance of an Investigational New Drug application, or its equivalent in China, means a regulator has allowed a study to proceed — it is not an endorsement of the drug and says nothing about whether it works. Earlier versions of this page described these steps as "FDA approval" and "approval in China", which was incorrect.

HMI-115 side effects

Hope Medicine has not published adverse-event data for the androgenetic alopecia trials, and no peer-reviewed safety report for HMI-115 in hair loss has appeared. Company statements have described the Phase 1b as well tolerated, but a company summary of a 16-person open-label study is not a safety profile.

Any specific list of side effects for HMI-115 circulating online — injection-site reactions, headache, fatigue, digestive upset — is not sourced from published trial data. An earlier version of this page carried such a list; it has been removed because no source supports it. What can be said is that injected biologics as a class commonly cause injection-site reactions, and that prolactin has roles beyond the hair follicle, which is why long-term safety in a cosmetic indication is a genuine open question rather than a formality.

What did the Australian Phase 1b actually show?

The Phase 1b study (NCT05324293) treated 16 people with androgenetic alopecia in Australia over 24 weeks. The company announced a positive outcome by press release. That announcement has not been followed by a peer-reviewed publication, the study was small and early-phase, and results reported this way cannot establish either safety or effectiveness. The larger Phase 2 in China (NCT06118866, 192 men) is recorded as completed on the trial registry; its results are the ones worth watching, and they were not published at the time of writing.

Before you consider anything here

HMI-115 is an experimental injectable antibody. It cannot be prescribed, it is not sold as a medicine, and material offered online under that name is unregulated and of unverified identity and purity. Talk to a doctor or pharmacist before starting, stopping or combining any hair loss treatment, and before acting on trial results reported here or anywhere else.

References

ClinicalTrials.gov. To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period (Phase 1, Australia, 16 participants). NCT05324293. https://www.clinicaltrials.gov/study/NCT05324293

ClinicalTrials.gov. A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia (Phase 2, China, 192 participants). NCT06118866. https://www.clinicaltrials.gov/study/NCT06118866

ClinicalTrials.gov. A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain (Phase 2, 142 participants). NCT05101317. https://www.clinicaltrials.gov/study/NCT05101317

ClinicalTrials.gov. Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain (Phase 3, China, 540 participants, recruiting). NCT07318688. https://www.clinicaltrials.gov/study/NCT07318688

PR Newswire. (2024, June 14). Positive outcome from a phase IB study in Australia treating patients with androgenic alopecia. Retrieved from https://www.prnewswire.com/news-releases/positive-outcome-from-a-phase-ib-study-in-australia-treating-patients-with-androgenic-alopecia-302031051.html

PR Newswire. (2023, October 26). Chime Biologics and Hope Medicine enter manufacturing agreement to speed up the launch of first-in-class antibody drug HMI-115 targeting endometriosis and androgenic alopecia. Retrieved from https://www.prnewswire.com/news-releases/chime-biologics-and-hope-medicine-enter-manufacturing-agreement-to-speed-up-the-launch-of-first-in-class-antibody-drug-hmi-115-targeting-endometriosis-and-androgenic-alopecia-301968968.html