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Biotech pipeline tracker

Module 2 — Clinical trial intelligence · 9 candidates · AR · PROTAC · Stem Cell · Wnt · PGD2 · Cell Therapy

2PHASE III
6PHASE II
1NON-DRUG
5UNVERIFIED
9TOTAL
9SHOWING
PHASE
MECHANISM
INDICATION
CANDIDATE PROFILES9/9 CANDIDATES
PHASE III◆PIVOTAL TRIAL
NEGLIGIBLE SYSTEMIC
KX-826 (Pyrilutamide)Pyrilutamide
Selective non-steroidal topical androgen receptor antagonist
KINTOR PHARMACEUTICAL
ANDROGEN RECEPTORMale AGAFemale AGA
N=560NCT05139836
PRIMARY ENDPOINT

Change from baseline in target area hair count at 24 weeks vs. vehicle

NEXT CATALYST

US Phase III data readout · NDA filing preparation 2026

PHASE 3
EST. COMPLETION: 2025-Q4
PHASE II⚡FAST TRACK
LOW SYSTEMIC
GT20029
AR-PROTAC targeted androgen receptor degrader — topical small molecule
KINTOR PHARMACEUTICAL
ANDROGEN RECEPTORMale AGAAcne
N=200NCT05437016
PRIMARY ENDPOINT

Change from baseline in total area hair count (TAHC) at 12 weeks vs. placebo

NEXT CATALYST

Phase II AGA data readout 2026 · Phase III initiation for AGA 2026

PHASE 2
EST. COMPLETION: 2026-Q3
PHASE II✓PRIMARY ENDPOINT MET→PHASE III PLANNING
LOW SYSTEMIC
PP405
Hair follicle stem cell reactivator — small molecule Wnt/Notch pathway modulator
PELAGE PHARMACEUTICALS
OTHERAGA
N=80NCT05422885
PRIMARY ENDPOINT

Incidence of treatment-related adverse events, with plasma concentration as key secondary (Phase 2a)

NEXT CATALYST

Phase IIb dose optimisation · Phase III planning and partner discussions 2025–2026

PHASE 2
EST. COMPLETION: 2024-Q4
NON-DRUG
CosmeRNA (SAMiRNA-AR68)
SIRNAGEN THERAPEUTICS / BIOMIMETIC TECHNOLOGIES
RNA/GENE
PRIMARY ENDPOINT

Change from baseline in total hair count at 24 weeks vs. placebo (investigator-run RCT)

NON-DRUG
PHASE III◆PIVOTAL TRIAL◈TOPLINE DATA 2026
NEGLIGIBLE SYSTEMIC
BreezulaClascoterone 5%
Cortexolone 17α-propionate 5% topical solution
COSMO PHARMACEUTICALS / SUN PHARMA
ANDROGEN RECEPTORMale AGA
N=1,465NCT04936529NCT05020119
PRIMARY ENDPOINT

TAHC — Target Area Hair Count change from baseline at 52 weeks vs. vehicle

NEXT CATALYST

Phase III 12-month topline data readout · NDA submission target 2026–2027

PHASE 3
EST. COMPLETION: 2026-Q1
PHASE II
LOW SYSTEMIC
SetipiprantKYTH-105
PGD2 receptor (CRTH2) antagonist — oral daily dosing
ALLERGAN / ABBVIE
OTHERMale AGA
N=169NCT02781116
PRIMARY ENDPOINT

Change in scalp hair count in target zone at 24 weeks vs. placebo

NEXT CATALYST

Final efficacy publication; no current Phase III announced

PHASE 2
EST. COMPLETION: 2024-Q3
PHASE II
NEGLIGIBLE SYSTEMIC
SM04554
Topical Wnt pathway activator — CLK2 splicing kinase inhibitor
BIOSPLICE THERAPEUTICS
WNT PATHWAYAGA
N=302NCT02995044
PRIMARY ENDPOINT

TAHC change from baseline; hair density by phototrichogram at 26 weeks

NEXT CATALYST

Program on hold — Biosplice pipeline reprioritisation 2024

PHASE 2
EST. COMPLETION: 2024-Q2
PHASE II
LOW SYSTEMIC
RCH-01
Autologous dermal sheath cup (DSC) cell therapy — intradermal injection
REPLICEL LIFE SCIENCES
CELL THERAPYAGA
N=160NCT01587066
PRIMARY ENDPOINT

Change in terminal hair density per cm² at 52 weeks post-injection

NEXT CATALYST

Final 52-week histology readout · Phase III partner discussions

PHASE 2
EST. COMPLETION: 2025-Q4
PHASE II
LOW SYSTEMIC
Topical Valproate
Sodium valproate 2% solution — class I HDAC inhibitor
SEOUL NATIONAL UNIVERSITY HOSPITAL
OTHERAGA
N=90NCT01846832
PRIMARY ENDPOINT

Global hair count and cross-sectional shaft diameter at 24 weeks

NEXT CATALYST

Academic publication; no commercial Phase III pathway announced

PHASE 2
EST. COMPLETION: 2024-Q4
BIOTECH_PIPELINE TIMELINEEXPANDABLE · MILESTONE VIEW
KX-826 (Pyrilutamide)Pyrilutamide
KINTOR PHARMACEUTICAL
ANDROGEN RECEPTORNCT05139836
Male AGA · Female AGA · N=560
PHASE III
2025-Q4
GT20029
KINTOR PHARMACEUTICAL
ANDROGEN RECEPTORNCT05437016
Male AGA · Acne · N=200
PHASE II
2026-Q3
PP405
PELAGE PHARMACEUTICALS
OTHERNCT05422885
AGA · N=80
PHASE II
2024-Q4
CosmeRNA (SAMiRNA-AR68)
SIRNAGEN THERAPEUTICS / BIOMIMETIC TECHNOLOGIES
RNA/GENE
NON-DRUG
BreezulaClascoterone 5%
COSMO PHARMACEUTICALS / SUN PHARMA
ANDROGEN RECEPTORNCT04936529+1
Male AGA · N=1,465
PHASE III
2026-Q1
SetipiprantKYTH-105
ALLERGAN / ABBVIE
OTHERNCT02781116
Male AGA · N=169
PHASE II
2024-Q3
SM04554
BIOSPLICE THERAPEUTICS
WNT PATHWAYNCT02995044
AGA · N=302
PHASE II
2024-Q2
RCH-01
REPLICEL LIFE SCIENCES
CELL THERAPYNCT01587066
AGA · N=160
PHASE II
2025-Q4
Topical Valproate
SEOUL NATIONAL UNIVERSITY HOSPITAL
OTHERNCT01846832
AGA · N=90
PHASE II
2024-Q4
NOTICE: Trial data compiled from ClinicalTrials.gov and company investor disclosures. Phase and timeline data may change; verify against source registries before any clinical or investment decisions.