Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06972264 | Safety and Efficacy of VDPHL01 in Males With AGA | PHASE3 | ACTIVE NOT_RECRUITING | 480 | — | — | Mar 11, 2025 | Jul 1, 2027 | Feb 12, 2026 | 44 | United States |
| NCT06724614 | Efficacy and Safety of VDPHL01 in Males With AGA | PHASE2 | ACTIVE NOT_RECRUITING | 480 | — | — | Nov 6, 2024 | Sep 1, 2026 | Nov 6, 2025 | 44 | United States |
| NCT06527365 | Safety and Efficacy of VDPHL01 in Males and Females With AGA | PHASE2 | ACTIVE NOT_RECRUITING | 70 | — | — | Jul 8, 2024 | Aug 1, 2026 | Nov 6, 2025 | 4 | United States |
Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.
Change from baseline in non-vellus TAHC using digital image analysis at Month 12.
| Arm | Type | Description |
|---|---|---|
| VDHPL01 BID | EXPERIMENTAL | VDPHL01 will be taken orally twice a day, once in the AM and once in the PM. |
| VDPHL01 QD and Placebo QD | EXPERIMENTAL | Placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM. |
| Placebo BID with treatment extension to VDPHL01 BID | PLACEBO_COMPARATOR | Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM. |
| Placebo BID with treatment extension to VDPHL01 QD and Placebo QD | PLACEBO_COMPARATOR | Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM. |
| VDPHL01 Tablet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| VDPHL01 | DRUG | VDPHL01 Extended Release (ER) Tablet |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subject is male aged 18-65 years old; * Subject has a clinical diagnosis of mild to moderate AGA; * Subject is in good general health and has adequate renal and hepatic function; * Subject is willing to maintain at least 1/4 inch length hair during the study with the same hair...