Drugs / DT-216P2
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | Friedreich ataxia | 2025-06-04 | “clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for DT-216P2.” designtx.com ↗ |
| Filed | US (FDA) | — | Friedreich ataxia | 2025-06-04 | “In addition, the company announced that it has submitted an investigational new drug (IND) application for DT-216P2 with the U.S. Food and Drug Administration (FDA).” designtx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06772870 | Feb → Sep 2025 overdue | Friedreich ataxia | Design Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06874010 | Jun 2025 → Dec 2026 expected | Friedreich ataxia | Design Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Design Therapeutics, Inc. | Results Design Therapeutics Announces Four-Week IV Data from the RESTORE-FA Trial of DT-216P2 Demonstrating Clinical Improvements and Comprehensive Biomarker Activity in Friedreich Ataxia designtx.com ↗ |
| 2025-08-07 | Design Therapeutics, Inc. | Results Design Therapeutics Highlights Progress Across Lead GeneTAC® Programs and Reports Second Quarter 2025 Financial Results designtx.com ↗
Today, Design announced early pharmacokinetics (PK) data for DT-216P2 demonstrating favorable translation from NHPs to humans with both intravenous (IV) and subcutaneous (SC) administration and an improved product profile compared to the prior DT-216 formulation (DT-216P1). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Design Therapeutics, Inc. | Design Therapeutics Announces Four-Week IV Data from the RESTORE-FA Trial of DT-216P2 Demonstrating Clinical Improvements and Comprehensive Biomarker Activity in Friedreich Ataxia designtx.com ↗ |
| 2026-05-17 | Design Therapeutics, Inc. | Design Therapeutics to Host Investor Webcast to Review Data from RESTORE-FA Trial of DT-216P2 for Friedreich’s Ataxia on Monday, May 18, 2026 designtx.com ↗ |
| 2025-08-07 | Design Therapeutics, Inc. | Design Therapeutics Highlights Progress Across Lead GeneTAC® Programs and Reports Second Quarter 2025 Financial Results designtx.com ↗ |
| 2025-06-04 | Design Therapeutics, Inc. | Design Therapeutics Announces Start of Friedreich Ataxia Patient Dosing Ex-U.S. in its RESTORE-FA Phase 1/2 Multiple-Ascending Dose Trial of DT-216P2 designtx.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DT-216P2 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06772870 ↗ |
| Route | Intravenous | “DT-216P2 will be administered as subcutaneous injection, subcutaneous infusion and intravenous infusion.” NCT06772870 ↗ |
| Route | Subcutaneous | “DT-216P2 will be administered as subcutaneous injection, subcutaneous infusion and intravenous infusion.” NCT06772870 ↗ |