Hair Loss Pipeline

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Last updated 2026-02-26
Approved 2
Phase 3 3
Phase 2 8
Phase 1 3
Preclinical 8
Compound Phase Type
Ritlecitinib
Litfulo
Approved Oral

Company

Pfizer

Status

approved

Est. Release

Available

Mechanism

JAK3/TEC Inhibitor

Summary

JAK inhibitor approved for alopecia areata (autoimmune). Does NOT work for male/female pattern baldness (AGA). Often confused but different conditions entirely.

Latest

FDA approved for alopecia areata (autoimmune hair loss). NOT for androgenetic alopecia.

ClinicalTrials.gov

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Baricitinib
Olumiant
Approved Oral

Company

Eli Lilly

Status

approved

Est. Release

Available

Mechanism

JAK1/JAK2 Inhibitor

Summary

Another JAK inhibitor for alopecia areata. Like ritlecitinib, does NOT treat androgenetic alopecia. Systemic drug with immune effects.

Latest

FDA approved for alopecia areata. Also approved for rheumatoid arthritis.

ClinicalTrials.gov

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Clascoterone
Breezula / CB-03-01 / Winlevi
Phase 3 Topical

Company

Cosmo Pharmaceuticals

Status

active

Est. Release

2027

Mechanism

Androgen Receptor Antagonist

Summary

Topical anti-androgen that blocks DHT at the scalp without systemic effects. 1% already FDA approved for acne (Winlevi). 5% concentration in Phase 3 (SCALP trials) showed dramatic hair count improvements - 539% and 168% relative improvement vs placebo with minimal systemic exposure. Would be first new AGA mechanism in 30+ years if approved.

Latest

Phase 3 SCALP 1 & 2 trials completed Dec 2025. 5% concentration showed 539% improvement (SCALP 1) and 168% improvement (SCALP 2) vs vehicle in Target Area Hair Count. 1,465 men enrolled. FDA/EMA submissions expected after spring 2026 safety follow-up completion.

ClinicalTrials.gov
Pyrilutamide
KX-826 / Koshine
Phase 3 Topical

Company

Kintor Pharmaceutical

Status

active

Est. Release

TBD

Mechanism

Androgen Receptor Antagonist

Summary

Topical androgen receptor antagonist. Company-reported Phase 2-stage data in a pivotal Phase 2/3 trial met the primary endpoint vs placebo, with Phase 3-stage completion expected in early 2026. Final confirmatory data is still needed.

Latest

Kintor press release (Jul 2025): Phase 2 stage of a pivotal Phase 2/3 trial met the primary endpoint vs placebo. Both 0.5% and 1.0% BID improved Target Area Hair Count and hair thickness at Week 24. Phase 3 stage enrollment completed (666 patients) and the trial is expected to complete in early 2026. Final Phase 3 results still pending.

ClinicalTrials.gov
VDPHL01
Veradermics
Phase 3 Oral

Company

Veradermics

Status

active

Est. Release

2027-2028

Mechanism

Extended-Release Minoxidil

Summary

Extended-release oral minoxidil designed to reduce peak exposure vs immediate-release oral minoxidil. Non-hormonal approach (doesn't touch DHT). In Phase 3 development for pattern hair loss, with topline Phase 3 data expected in 2026 per company guidance.

Latest

Company press release (Feb 2026): completed enrollment in the second pivotal Phase 3 trial for male pattern hair loss (~1,000 male patients across studies). Topline data expected 1H 2026 (initial trial) and 2H 2026 (confirmatory trial). Female Phase 2/3 trial recruiting (NCT07146022).

ClinicalTrials.gov
Dutasteride Topical Solution
0.05% topical dutasteride
Phase 2 Topical

Company

Shilpa Medicare

Status

active

Est. Release

TBD

Mechanism

5-alpha Reductase Inhibitor (Type I & II)

Summary

Investigational topical dutasteride formulation designed to concentrate 5-alpha reductase inhibition in the scalp while limiting systemic DHT suppression. Phase 2 data suggests 0.05% may improve hair counts vs placebo and compare favorably to oral finasteride, but larger confirmatory trials and long-term safety are needed.

Latest

Phase 2, randomized controlled study (135 men, 24 weeks) comparing a novel dutasteride topical solution (0.05% and 0.01%) vs placebo and oral finasteride 1mg. 0.05% showed the largest improvements in Target Area Hair Count and hair thickness at Week 24, with modest changes in serum DHT/testosterone (CTRI/2021/03/032173). Funded by Shilpa Medicare; authors report a related patent filing.

GT20029
AR-PROTAC
Phase 2 Topical

Company

Kintor Pharmaceutical

Status

active

Est. Release

2027-2028

Mechanism

PROTAC Androgen Receptor Degrader

Summary

First-in-class PROTAC technology that degrades androgen receptors rather than just blocking them. Novel mechanism could be more effective than traditional anti-androgens. Phase 2 showed all treatment groups had hair count increases vs placebo.

Latest

Phase 2 complete. Phase 3 started 2025, expected to finish ~2026. Market release 2027-2028 if successful.

ClinicalTrials.gov
PP405
Phase 2 Topical

Company

Pelage Pharmaceuticals

Status

active

Est. Release

2028-2029

Mechanism

Mitochondrial Pyruvate Carrier (MPC) Inhibitor

Summary

Novel MPC inhibitor that reprograms hair follicle metabolism, pushing stem cells from oxidative phosphorylation into a glycolytic state (mimicking active growth phase). NOT an androgen blocker - works on men and women. Backed by ARCH Ventures and Google Ventures. Fast response in trials (8 weeks vs typical 6-12 months).

Latest

Phase 2a complete. BioSpace (Feb 2026) interview: first part of 2026 spent engaging with FDA to confirm Phase 3 trial design and endpoints; Phase III described as in planning stages. Full results still expected to be presented at a medical meeting (often rumored as AAD March 2026). Phase 3 enrollment previously stated as expected to begin mid-2026 per CMO Christina Weng (Jan 2026). Earlier Phase 2a data: 31% of men showed >20% hair density increase at 8 weeks (vs 0% placebo). No systemic absorption detected. $120M Series B funding secured.

ClinicalTrials.gov

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Verteporfin
Visudyne
Phase 2 Injectable

Company

Various (Off-label)

Status

active

Est. Release

TBD

Mechanism

YAP/TAZ Inhibitor (Scarless Healing)

Summary

Originally for eye disease, now being tested for scarless healing in hair transplants. Could enable unlimited donor harvesting by preventing scar formation. Potentially game-changing for transplant patients.

Latest

Multi-center trial recruitment ongoing. FDA approved for macular degeneration, being explored for scarless wound healing in transplants.

ClinicalTrials.gov
HMI-115
BAY-1158061
Phase 2 Subcutaneous Injection

Company

Bayer / Hope Medicine

Status

active

Est. Release

2027

Mechanism

Prolactin Receptor Monoclonal Antibody

Summary

Monoclonal antibody blocking prolactin receptors in hair follicles. Phase 1b showed +14 hairs/cm² over 24 weeks. Completely different mechanism from anti-androgens - targets PRLR pathway. Licensed from Bayer. Macaque monkey studies showed dramatic regrowth.

Latest

Phase 2 completed Nov 2024, results pending. Phase 1b showed +14 hairs/cm² in males. Company targeting 2027 release.

ClinicalTrials.gov
DLQ01
Phase 2 Topical

Company

Dermaliq Therapeutics

Status

active

Est. Release

2028+

Mechanism

Prostaglandin F2α Analog

Summary

Topical prostaglandin F2α analog with proprietary hyliQ® carrier technology that delivers active ingredients directly into hair follicles. More direct than minoxidil - doesn't need enzyme conversion, works directly on PGF receptors to extend anagen phase. Can be stacked with minoxidil.

Latest

Phase 1b/2a completed July 2024. 12.3% TAHC increase (p=0.008), 83% response rate. Beat minoxidil (9.8%). For men and women.

Follicopeptide
FOL-005 / FOL005
Phase 2 Topical

Company

Coegin Pharma

Status

active

Est. Release

Ccosmetic

Mechanism

Osteopontin Peptide (Stem Cell & Angiogenesis)

Summary

Modified osteopontin peptide that activates stem cells, promotes blood vessel growth around follicles. Launched as cosmetic (not drug) for faster market access. Trial results showed ~12 hairs/cm² increase after 4 months - comparable to finasteride. Originally developed by Follicum, acquired by Coegin Pharma.

Latest

Now commercially available as cosmetic product via Scandinavian Biolabs and Hårklinikken partnerships (€170 for 2 bottles). ~12 hairs/cm² increase in trials - similar to finasteride.

RU-58841
PSK-3841 / HMR-3841
Phase 2 Topical

Company

Roussel Uclaf / ProStrakan

Status

discontinued

Est. Release

Gray market

Mechanism

Non-steroidal Androgen Receptor Antagonist

Summary

Topical anti-androgen that blocks DHT at the receptor (unlike fin which blocks DHT production). Developed 1980s, trials abandoned ~2010. Related to nilutamide/bicalutamide. Popular in community but sold as 'research chemical' - no FDA approval, no quality control.

Latest

Phase 1/2 trials completed but abandoned ~2010. Now sold as gray market 'research chemical'.

AMP-303
SCUBE3
Phase 1 Injectable

Company

Amplifica

Status

active

Est. Release

2028+

Mechanism

Signaling Molecule (Hair Follicle Activation)

Summary

Novel polysaccharide intradermal injectable that activates dormant hair follicles using unique signaling molecules. Nature-inspired approach from UCI research. Phase 1 showed 15% hair increase in 60 days. Co-founded by hair transplant surgeon Dr. William Rassman.

Latest

Phase 1 completed Jan 2025. 15% increase in non-vellus hair at 60 days. Results presented at 2025 SID meeting. Co-founded by Dr. William Rassman (active on r/tressless).

ET-02
Phase 1 Topical

Company

Eirion Therapeutics

Status

active

Est. Release

2028+

Mechanism

PAI-1 Inhibitor (Stem Cell Activation)

Summary

PAI-1 inhibitor that targets stem cell biology to restore normal hair follicle function. Phase 1 showed 6-fold increase in non-vellus hair in just 5 weeks - outperformed 4 months of minoxidil. Also may reverse hair graying. Non-hormonal, no sexual side effects expected. Being tested in oral form too.

Latest

Phase 1 completed Jan 2025 with unprecedented results. 6-fold increase in hair count in 5 weeks. Phase 2 with ~150 participants planned for 2025.

OLX104C
OLX72021
Phase 1 Injectable

Company

OliX Pharmaceuticals

Status

active

Est. Release

2027+

Mechanism

RNA Interference (Androgen Receptor silencing)

Summary

Korean biotech using asymmetric siRNA (asiRNA) to silence androgen receptor expression in hair follicles. Unlike DHT blockers, targets the receptor itself. Injected locally into scalp, rapidly degrades in blood - potentially avoiding sexual dysfunction and depression. Single dose inhibits AR for 3+ weeks.

Latest

Phase 1 started June 2023 in Australia. Enrolling 120 men across 10 sites. 30-month trial. Scalp injection that degrades in blood - avoids systemic side effects.

ABS-201
Preclinical Subcutaneous Injection

Company

AbSci

Status

active

Est. Release

2029-2030

Mechanism

Prolactin Receptor Monoclonal Antibody

Summary

AI-designed prolactin receptor antibody targeting PRLR. Preclinical: 100% regrowth in mice in 22 days (vs 5% minoxidil), extends growth phase 20-30%, expands stem cells, restores IGF-1/FGF-7, no shedding phase. Dosing every 3-6 months. Similar mechanism to HMI-115.

Latest

Phase 1/2a (HEADLINE trial) planned late 2025/early 2026. Overseen by Dr. Rodney Sinclair. Dosing every 3-6 months.

Hair Cloning
YCH001
Preclinical Cell Therapy

Company

Yunce Medical

Status

research

Est. Release

2027

Mechanism

iPSC-derived Hair Follicle Regeneration

Summary

Chinese biotech pursuing iPSC-derived hair follicle regeneration, similar to Stemson's approach. Claims >90% CD200 positive cell differentiation (vs 30% in literature). Based in Chengdu, partnered with West China Hospital. Positioning as Stemson's successor after their shutdown.

Latest

Animal trials complete. Human clinical trials planned for 2026. Seeking $2M funding. Partnership with West China Hospital of Sichuan University.

2-Deoxy-D-Ribose
2dDR / Deoxyribose Sugar
Preclinical Topical

Company

University of Sheffield

Status

research

Est. Release

TBD

Mechanism

Angiogenesis (Blood Vessel Formation)

Summary

A naturally occurring sugar molecule (part of DNA backbone) that promotes blood vessel formation. Sheffield/COMSATS researchers noticed faster hair growth around healing wounds treated with 2dDR. Mouse study showed similar efficacy to minoxidil. Very early stage - researchers explicitly warned against companies selling it prematurely.

Latest

Published June 2024 in Frontiers in Pharmacology. Mouse study showed 2dDR gel 80-90% as effective as minoxidil. Researchers cautioned against premature use - no human safety/efficacy data yet.

MicroRNA Therapy
miR-218-5p
Preclinical Topical

Company

Various (Research)

Status

research

Est. Release

2029+

Mechanism

Gene Expression Modulation

Summary

Research showing specific microRNAs can trigger significant hair regrowth in mice by softening stiffened stem cells. Northwestern's June 2023 study is the most recent. Promising but very early - years from human trials.

Latest

Northwestern study (June 2023) showed softening stem cells via miR-205 restored hair growth in aged mice. Still preclinical, no human trials announced.

Exosomes
Preclinical Injectable

Company

Various

Status

research

Est. Release

2029+

Mechanism

Extracellular Vesicle Signaling

Summary

Extracellular vesicles that carry growth factors and signaling molecules. Early studies show potential for stimulating hair growth. Still very experimental with no standardized protocols or advanced trials.

Latest

Still in pilot and preclinical studies. No advanced clinical phase expected before 2026.

Oleic Acid Serum
Preclinical Topical

Company

National Taiwan University

Status

research

Est. Release

TBD

Mechanism

Hair Follicle Stem Cell Activation via Fatty Acid Metabolism

Summary

Serum using monounsaturated fatty acids (oleic acid, palmitoleic acid) dissolved in alcohol. Developed by Prof. Sung-Jan Lin at NTU. Activates hair follicle stem cells by mimicking the fat breakdown that occurs during skin healing. No DHT involvement - completely different pathway. Promising mouse data but years from human validation.

Latest

Published in Cell Metabolism Oct 2025. Mouse studies showed hair regrowth in 20 days. Professor Lin self-tested on leg with results in 3 weeks. Human scalp trials planned, no timeline.

Bee Venom (Melittin)
Apitoxin
Preclinical Topical

Company

Various (Research)

Status

research

Est. Release

TBD

Mechanism

IGF-1/VEGF Upregulation + Controlled Irritation

Summary

Mouse studies comparing 0.001% bee venom to 2% minoxidil showed bee venom outperformed in regrowth speed. Proposed mechanism: melittin increases IGF-1 and VEGF around follicles, reduces inflammation, creates controlled irritation similar to microneedling. Major caveat: severe allergic reactions possible. No human trials, purely animal data.

Latest

Mouse studies showed 0.001% bee venom outperformed 2% minoxidil in regrowth speed. No human trials. Allergy risk is major concern.

Hair Cloning
Preclinical Cell Therapy

Company

Stemson Therapeutics

Status

discontinued

Mechanism

iPSC-derived Hair Follicle Cells

Summary

Was the leading company pursuing iPSC-derived hair follicle regeneration - the 'holy grail' of unlimited donor hair. Shut down in Dec 2024 before reaching human trials. Yunce Medical (China) is now pursuing similar technology.

Latest

Company shut down Dec 2024. Was the leading hair cloning research company in the US.

Established Treatments

FDA-approved or widely used for androgenetic alopecia.

Finasteride

Propecia / Proscar
Oral

5-alpha Reductase Inhibitor (Type II)

Gold standard DHT blocker. Blocks ~70% of DHT. FDA approved for AGA. Well-studied, effective for most. Some report sexual side effects (1-2%).

Dutasteride

Avodart
Oral

5-alpha Reductase Inhibitor (Type I & II)

Stronger than finasteride - blocks ~90% of DHT. FDA approved for BPH, used off-label for AGA. Often used when fin alone isn't enough.

Minoxidil

Rogaine / Regaine
Topical/Oral

Potassium Channel Opener (Vasodilator)

Stimulates hair growth via increased blood flow. Works independently of DHT. Topical OTC or oral (off-label, more effective). Warning: toxic to cats.

Microneedling

Dermaroller / Dermapen
Device

Wound Healing / Wnt Pathway Activation

Creates micro-wounds that stimulate healing response and Wnt signaling. Often used with minoxidil to enhance absorption. Weekly at 1.5mm depth.