Topic
Hair growth pipeline (2026)
What is in clinical trials for hair loss as of October 2026, how far along it is, and how much to trust the early numbers.
Key takeaways
- Nothing in the pipeline has yet beaten the current standard (minoxidil, finasteride and dutasteride, light and needling procedures, transplants) in a published, peer-reviewed, controlled trial for pattern hair loss.
- Closest to market for pattern hair loss: extended-release oral minoxidil (VDPHL01) from Veradermics, with phase 3 trials running in men and women, and sublingual minoxidil (phase 3 completed May 2026, no results posted). Both are new forms of an old drug. See minoxidil forms compared.
- Most interesting new mechanism: PP405, which wakes follicle stem cells. Phase 2a showed no blood absorption and company-reported density gains in men with more hair loss; a 600-man phase 2/3 began enrolling in September 2026 (trial record).
- Biologics: the prolactin-receptor antibodies HMI-115 (phase 2 done, results not public) and Absci's ABS-201 (early trial, interim hair data promised late 2026, full data early 2027).
- Autoimmune alopecia areata is far ahead of pattern hair loss: three JAK inhibitors are approved and upadacitinib is under review. See JAK inhibitors and hair.
- Failures matter: setipiprant and SM04554 both failed against placebo in humans, and bimatoprost on the scalp failed too (bimatoprost). Mouse and dish results rarely transfer.
- Be careful with early company numbers: most phase 2 headlines come from press releases, small subgroups or registry entries, not peer-reviewed papers.
The science
Pattern hair loss (androgenetic alopecia)
| Candidate | Sponsor | Type | Status (10 Oct 2026) | What is known |
|---|---|---|---|---|
| VDPHL01 | Veradermics | Extended-release oral minoxidil | Phase 2/3 in men completed; phase 3 trials in men and women running | Company reported +30.3 and +33.0 versus +7.3 non-vellus hairs/cm2 at 6 months in men; press release, not peer reviewed (trial record) |
| Sublingual minoxidil | Samson Clinical | Sublingual tablet | Phase 3 complete, no results | Phase 1b and a 110-man RCT versus oral 5 mg: equal efficacy, fewer palpitations |
| TH07 | Triple Hair Inc | Minoxidil, finasteride and latanoprost solution | Phase 3 in 420 men, started April 2026, ends December 2027 | First large test of latanoprost on the scalp (trial record) |
| PP405 | Pelage | Topical gel, pyruvate carrier inhibitor | Phase 2a done; phase 2/3 AWAKEN started September 2026 | 31% of men with more hair loss gained over 20% density at week 8 versus 0% on vehicle (company-reported); no blood exposure (trial record) |
| HMI-115 | Hope Medicine | Anti-prolactin-receptor antibody injection | Phase 2 in 192 men done August 2024 | Phase 1b: +14 hairs/cm2 in 12 men (company, no control); phase 2 unreported |
| ABS-201 | Absci | Anti-prolactin-receptor antibody injection | Early trial from December 2025 | Company reported blinded safety data from 32 volunteers in June 2026; efficacy interim late 2026 |
| TDM-105795 | Technoderma | Topical thyroid receptor beta agonist | Phase 2 in 71 men done 2023 | +20.3 and +22.4 versus +14.0 hairs on vehicle; no clear separation (trial record) |
| AMP-303 | Amplifica | Intradermal injection | Not found on the trial registry under that name | Press reports of over 15% non-vellus gain at 60 days; no peer-reviewed data |
| Topical rapamycin, metformin | various | Longevity-pathway drugs | Mentioned in a 2026 review | Preclinical or early (Agrawal 2026) |
Antiandrogen candidates such as clascoterone and pyrilutamide are covered with the other androgen-pathway drugs.
Failed human trials worth knowing
| Candidate | Result |
|---|---|
| Setipiprant, 169 men, 24 weeks | Hair count +7.1 versus +6.7 on placebo (P=0.92) (trial record) |
| SM04554, 302 and 675 men | No benefit versus vehicle (trial record) |
| Bimatoprost scalp programme | Small or no gains versus minoxidil |
| Ruxolitinib 1.5% cream for alopecia areata | No better than vehicle (Olsen 2020) |
Preclinical science that may become drugs
- UK-5099 (lactate and stem cell activation, the basis of PP405-type approaches), WAY-316606 (SFRP1), PTD-DBM (CXXC5), thymosin beta-4 and valproic acid, the only Wnt activator with a small positive human trial.
Alopecia areata and other autoimmune hair loss
- Upadacitinib: FDA submission in April 2026 and EMA review; at least 80% scalp hair at week 24 in 45% (15 mg) and 55% (30 mg) (Mostaghimi 2026).
- Other JAK candidates (jaktinib, ivarmacitinib), the anti-IL-7 receptor antibody bempikibart, dupilumab, ritlecitinib in moderate disease and topical delgocitinib in frontal fibrosing alopecia are in trials; we have not read their results.
What it means by hair profile
- Almost all pattern-hair-loss candidates enrol men with Norwood IV to V loss or mixed groups. Women have fewer trials; the women's VDPHL01 phase 3 and an oral minoxidil 1 mg trial are exceptions.
- Mechanisms that do not depend on androgens (stem-cell activation, prolactin-receptor blockade, minoxidil delivery) may suit women and people who cannot take finasteride or dutasteride, but no data prove that.
- Hair type (curl pattern, thickness) is not stratified in any registered trial found.
Myths and facts
- Myth: a positive phase 2 means it works. Fact: setipiprant and SM04554 reached phase 2 on good lab data and showed nothing in humans.
- Myth: peptides and research chemicals bought online (TB-500, WAY-316606, UK-5099, PTD-DBM) are early access to the pipeline. Fact: they are unapproved research chemicals with no human hair data.
- Myth: the pipeline will replace finasteride and minoxidil soon. Fact: every serious candidate is being added to, or measured against, those drugs.
Practical recommendations
- Use proven treatments now (minoxidil, finasteride) and watch for 2026 to 2027 readouts: VDPHL01 phase 3, PP405 phase 2/3 (primary completion December 2027), ABS-201 interim data and the upadacitinib FDA decision for alopecia areata.
- Joining a registered trial is the legitimate route to experimental drugs; ClinicalTrials.gov lists them.
Bottom line
The pipeline is promising but unproven; most numbers are company-reported. Treat anything not yet approved as information, not advice. Discuss with a doctor.
Studies 12
Agrawal A et al. Emerging pharmacotherapies for androgenetic alopecia. Expert Opin Pharmacother. 2026
Tested: emerging drugs including HMI-115, ABS-201, KB-141
Result: Groups HMI-115 and ABS-201 as antibodies that block the prolactin receptor, a route that does not depend on androgens.
Read the study ↗ClinicalTrials.gov NCT06724614. Extended-release oral minoxidil (VDPHL01) in men with pattern hair loss, phase 2/3. Veradermics
Tested: extended-release oral minoxidil vs placebo
Result: The company reported +30.3 and +33.0 vs +7.3 non-vellus hairs/cm2 at 6 months in a press release in April 2026; no peer-reviewed paper yet.
Read the study ↗ClinicalTrials.gov NCT06393452. Safety, pharmacokinetics and efficacy of PP405 in adults with androgenetic alopecia. Pelage Pharmaceuticals
Tested: PP405 0.05% gel once daily vs vehicle
Result: Safety endpoint met with no PP405 detectable in blood; the company reported hair density rising over 20% at week 8 in 31% of men with more advanced loss vs 0% on vehicle.
Read the study ↗ClinicalTrials.gov NCT07819435. Phase 2/3 efficacy and safety of PP405 in adult males with NHS type IV-V androgenetic alopecia. Pelage Pharmaceuticals
Tested: PP405 0.05% gel once daily vs vehicle
Result: Enrolling since September 2026; no results yet.
Read the study ↗ClinicalTrials.gov NCT05324293. Phase 1b study of HMI-115 in androgenetic alopecia. Hope Medicine
Tested: HMI-115 anti-prolactin-receptor antibody injections, open-label
Result: The company reported an average gain of 14 non-vellus hairs/cm2 in the men; no control group.
Read the study ↗ClinicalTrials.gov NCT06118866. Phase 2 study of HMI-115 in men with androgenetic alopecia. Hope Medicine
Tested: HMI-115 vs placebo
Result: Completed 26 August 2024; no results have been posted or published.
Read the study ↗Show 6 more studies
ClinicalTrials.gov NCT05802173. Phase 2 study of TDM-105795 in men with androgenetic alopecia. Technoderma
Tested: topical TDM-105795 0.0025% or 0.02% vs vehicle
Result: Hair count rose 20.3 and 22.4 vs 14.0 on vehicle; hair width did not improve and no significance was reported.
Read the study ↗ClinicalTrials.gov NCT02781311. A safety and efficacy study of setipiprant tablets in androgenetic alopecia in males. Allergan
Tested: setipiprant 1000 mg twice daily vs placebo
Result: Target-area hair count changed by 7.1 vs 6.7 on placebo (difference 0.4, P=0.92); self-assessment was also no different.
Read the study ↗ClinicalTrials.gov NCT03742518. SM04554 topical solution in men with androgenetic alopecia, phase 2/3. Biosplice
Tested: SM04554 0.15% or 0.25% vs vehicle
Result: Week-48 hair count ratio versus vehicle was 1.024 (P=0.54) and 1.014 (P=0.745): no significant benefit.
Read the study ↗Olsen EA et al. Ruxolitinib cream for the treatment of patients with alopecia areata. J Am Acad Dermatol. 2020
Tested: ruxolitinib 1.5% cream vs vehicle
Result: The open-label part looked promising, but the double-blind part showed no significant difference from vehicle.
Read the study ↗ClinicalTrials.gov NCT07435012. Phase III trial of TH07 topical treatment in men with androgenic alopecia. Triple Hair Inc
Tested: topical minoxidil, finasteride and latanoprost combination
Result: Registered phase 3 trial that began in April 2026 with primary completion expected December 2027; no results yet.
Read the study ↗Mostaghimi A et al. Upadacitinib for severe alopecia areata in adults and adolescents: two phase 3 UP-AA randomized clinical trials. JAMA Dermatol. 2026
Tested: upadacitinib 15 mg or 30 mg daily vs placebo
Result: At least 80% scalp hair at week 24 in 45.2% and 44.6% (15 mg), 55.0% and 54.3% (30 mg) vs 1.5% and 3.4% on placebo; sponsor-funded.
Read the study ↗Related
- PP405An experimental once-daily scalp gel that wakes dormant follicle stem cells; a small phase 2a trial found no blood absorption, and a 600-man trial began enrolling in September 2026.
- HMI-115An injected antibody that blocks the prolactin receptor, with a small open-label hair gain and an unreported 192-man phase 2 trial in men.
- TDM-105795A topical thyroid-hormone-receptor-beta agonist tested in 71 men in 2023; hair counts rose a little more than on vehicle, with no significance reported and no phase 3 since.
- SetipiprantAn oral blocker of the PGD2 receptor GPR44 that was tested for male pattern baldness on strong lab data and grew no more hair than placebo in 169 men.
- SM04554 (dalosirvir)A topical Wnt-pathway activator tested in about a thousand men with pattern baldness that showed no significant benefit over vehicle.
- BimatoprostA prostaglandin-like eye medicine that grows longer, thicker, darker eyelashes (and helps eyebrows), but did not work on the scalp.
- UpadacitinibA JAK1 pill already approved for other diseases that gave 45 to 55% of people with severe alopecia areata near-full scalp hair in two 2026 trials and is under regulatory review for hair.
- MinoxidilThe most widely used hair-growth treatment, available as a cheap over-the-counter lotion or foam and as a prescription tablet, with a mechanism that is still only partly understood.
- FinasterideA prescription pill (and in some countries a scalp spray) that lowers DHT and is the best-proven drug for stopping male pattern hair loss.
- Minoxidil forms comparedSolution, foam, oral tablets, sublingual and extended-release minoxidil deliver the same drug in different ways; this page compares them.
- JAK inhibitors and hairJanus kinase (JAK) inhibitors are pills that regrow hair in severe alopecia areata, but they are not treatments for ordinary pattern thinning.