Drugs / SRP-1005
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | Huntington disease | 2026-01-07 | “today announced the submission of its clinical trial application (CTA) for Study SRP-1005-101, also known as INSIGHTT, to Medsafe” sarepta.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07536061 | May 2026 → Nov 2027 expected | Huntington disease | Sarepta Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Sarepta Therapeutics, Inc. | Regulatory Sarepta Therapeutics Announces Approval of Clinical Trial Application for SRP-1005, Its Investigational Treatment for Huntington’s Disease sarepta.com ↗
today announced that Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, has granted approval for its clinical trial application (CTA) for Study SRP-1005-101, also known as INSIGHTT. |
| 2026-01-07 | Sarepta Therapeutics, Inc. | Regulatory Sarepta Therapeutics Announces Submission of Clinical Trial Application for SRP-1005, its Investigational Treatment for Huntington’s Disease sarepta.com ↗
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the submission of its clinical trial application (CTA) for Study SRP-1005-101, also known as INSIGHTT, to Medsafe, the New Zealand Medicines and Medical Devices Safety Authority. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Sarepta Therapeutics, Inc. | Sarepta Therapeutics Announces Approval of Clinical Trial Application for SRP-1005, Its Investigational Treatment for Huntington’s Disease sarepta.com ↗ |
| 2026-01-07 | Sarepta Therapeutics, Inc. | Sarepta Therapeutics Announces Submission of Clinical Trial Application for SRP-1005, its Investigational Treatment for Huntington’s Disease sarepta.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SRP-1005 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07536061 ↗ |
| Route | Subcutaneous | “Subcutaneous injection” NCT07536061 ↗ |