Trials / Approved For Marketing
Approved For MarketingNCT05286372
An Intermediate Size Expanded Access Protocol of AMX0035 for ALS
An Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Amylyx Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The Expanded Access Program will provide access and assess the safety of AMX0035 for the treatment of people living with ALS.
Detailed description
AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the endoplasmic reticulum (ER) and mitochondria. This Expanded Access Program is designed to provide expanded access to AMX0035 for the treatment of people living with ALS and assess safety in diverse populations/stages of ALS over 48 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMX0035 | Proprietary formulation of sodium phenylbutyrate and taurursodiol |
Timeline
- First posted
- 2022-03-18
- Last updated
- 2022-10-18
Locations
21 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT05286372. Inclusion in this directory is not an endorsement.