Hair Loss Pipeline

No blogspam, just data.

Updated 2026-01-07
Approved 2
Phase 3 3
Phase 2 5
Phase 1 3
Preclinical 7
Compound Phase Type
Ritlecitinib
Litfulo
Approved Oral

Company

Pfizer

Status

approved

Est. Release

Available (AA only)

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 (AA only)

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

Cassiopea

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). Higher concentrations (2.5-7.5%) being tested for hair loss. Phase 3 results show statistically significant hair count increases vs placebo.

Latest

Phase 3 topline results released Dec 2025. Testing 2.5-7.5% concentrations for AGA. Market release estimated 2027 if approved.

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

Company

Kintor Pharmaceutical

Status

active

Est. Release

2027 (China)

Mechanism

Androgen Receptor Antagonist

Summary

Topical anti-androgen that failed to show statistical significance vs placebo in Phase 3. Now being sold as cosmetic to bypass approval. Long-term safety data showed modest results (46% got ≥10 hairs/cm² over 52 weeks). Kintor's GT20029 is now seen as more promising.

Latest

Phase 3 (0.5%) failed primary endpoint Nov 2023 - no statistical significance vs placebo. New 1% trial ongoing but Phase 2 showed minimal improvement over 0.5%. Already sold as cosmetic (Koshine) on Amazon. NDA submission to China expected 2026.

ClinicalTrials.gov
GT20029
AR-PROTAC
Phase 3 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 - 31% of men showed >20% hair density increase at 8 weeks (vs 0% placebo). No systemic absorption detected. Phase 2b expected to finish end of 2025, Phase 3 by 2027. $120M Series B funding secured.

ClinicalTrials.gov
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
VDPHL01
Veradermics
Phase 2 Oral

Company

Veradermics

Status

active

Est. Release

2027-2028

Mechanism

Extended-Release Minoxidil

Summary

Extended-release oral minoxidil designed to minimize cardiovascular side effects seen with regular oral min. Non-hormonal approach (doesn't touch DHT). Phase 2/3 showing impressive early results. Major funding and fast-tracking suggest serious commercial intent.

Latest

Phase 2/3 enrollment completed Dec 2025. +47.3 hairs/cm² at 4 months with 95% satisfaction rate. $150M Series C secured Oct 2025. FDA approval expected late 2027 - mid 2028.

ClinicalTrials.gov
HMI-115
Phase 2 Injectable

Company

Hope Medicine

Status

active

Est. Release

2027

Mechanism

Prolactin Receptor 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
Follicopeptide
FOL-005 / FOL005
Phase 2 Topical

Company

Coegin Pharma

Status

active

Est. Release

2025-2026

Mechanism

Osteopontin Peptide (Stem Cell & Angiogenesis)

Summary

Modified osteopontin peptide that activates stem cells, promotes blood vessel growth around follicles. Launching 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

Launching as cosmetic late 2025/early 2026 via Scandinavian Biolabs and Hårklinikken partnerships. ~12 hairs/cm² increase in trials - similar to finasteride.

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.

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.