Last updated 22 Oct 2025
As of October 2025, VDPHL01 remains in an ongoing Phase 2/3 trial. Primary completion is scheduled for 1 July 2026 (NCT06724614).
From trial completion to market — typical steps
- Database lock & statistical analysis (≈ 3‒6 months)
Cleaning, adjudication and final analysis of efficacy/safety data. - NDA / MAA preparation (≈ 3 months)
Common Technical Document assembly, manufacturing dossier, labelling. - Regulatory review
• FDA standard review: 10 months
• FDA priority review (if granted): 6 months
• EMA (centralised): ~12 months (clock-stop not included) - First marketing authorisation → sequential filings in other regions.
- Commercial launch: manufacturing scale-up, pricing, reimbursement.
With a primary completion in July 2026, an optimistic earliest approval would be late 2027 (priority review). A conservative scenario (standard review + potential queries) shifts first market launch to 2028.
Key uncertainties
- Clinical outcome: efficacy may not meet predefined endpoints.
- Safety profile: unforeseen cardiovascular or endocrine signals could delay approval.
- Manufacturing readiness: scale-up of an oral solid dose is usually straightforward but still subject to GMP inspections.
Update archive
| Date | Event | Link |
|---|---|---|
| 2025-10-22 | ClinicalTrials.gov record confirms Active, not recruiting. | NCT06724614 |
| 2025-09-03 | Status changed from Recruiting → Active, not recruiting. | NCT06724614 |
| 2025-03-04 | Protocol v2.0 uploaded (dose-adjustment arm). | NCT06724614 |
| 2024-11-06 | First participant dosed; trial start. | NCT06724614 |
How to track future updates
- Bookmark the trial registry entry: NCT06724614.
- Subscribe to Veradermics’ press releases or RSS feed.
- Monitor FDA “Drugs@FDA” database after NDA submission.
Sources
- ClinicalTrials.gov — NCT06724614 (accessed 22 Oct 2025)
- Veradermics Investor Deck Q2 2025 (slide 14) [accessed 22 Oct 2025]
- FDA Guidance for Industry: Review Timelines (2019) [accessed 22 Oct 2025]