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INS1201 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1 | EXPERIMENTAL | Participants aged 3 to \<5 years will receive a single dose level 1 of INS1201 by IT injection on Day 1. |
| Part 1: Cohort 2 | EXPERIMENTAL | Participants aged 3 to \<5 years will receive a single dose level 2 of INS1201 by IT injection on Day 1. |
| Part 2: Cohort 3 | EXPERIMENTAL | Participants aged 2 to \<3 years will receive a single dose level 1 of INS1201 by IT injection on Day 1. |
| Part 2: Cohort 4 | EXPERIMENTAL | Participants aged 2 to \<3 years will receive a single dose level 2 of INS1201 by IT injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| INS1201 | GENETIC | Suspension for IT injection. |
Inclusion Criteria * Participant must be male at birth, 3 to \<5 years of age, inclusive (Part 1) and 2 to \<3 years of age (Part 2), at the time of legally authorized representative (LAR) signing and dating the informed consent form. * Ambulatory -as defined as the ability to walk at least 10 mete...
INS1201 is an investigational gene therapy being developed for the treatment of Duchenne Muscular Dystrophy (DMD) in ambulatory males. It is administered as a single intrathecal injection. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
INS1201 is being developed by Insmed Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol INSM. The company is conducting a Phase 1 clinical trial to evaluate the safety and biodistribution of this gene therapy in patients with Duchenne Muscular Dystrophy.
INS1201 is in Phase 1 clinical development. It is an investigational gene therapy for Duchenne Muscular Dystrophy and has not yet been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is currently recruiting participants in the United States.
INS1201 is being studied in a Phase 1 clinical trial registered as NCT06817382. This study investigates the safety and biodistribution of a single intrathecal injection of INS1201 in ambulatory males with Duchenne Muscular Dystrophy. The trial is recruiting 12 participants in the United States.
INS1201 is administered as a single intrathecal injection, meaning it is delivered directly into the spinal fluid. This route of administration is being studied in a Phase 1 clinical trial for ambulatory males with Duchenne Muscular Dystrophy. The trial is currently recruiting participants.