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TRO19622 · 2 trials · 2 indications
safety criteria will be: * Occurrence of AEs, * Physical examination, * Laboratory tests, * Vital signs and ECG,
| Arm | Type | Description |
|---|---|---|
| Olesoxime | OTHER | All patients will receive the IMP as add-on to riluzole 50 mg bid orally, 50 mg morning and evening on an empty stomach ie at least 20 min before the meal. |
| TRO19622 | EXPERIMENTAL | TRO19622 500 mg |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TRO19622 | DRUG | 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid |
| Placebo | DRUG | - |
Inclusion Criteria: * Patients must have completed the 18-month safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 1015-1). * Both the investigator and the patient will decide based on previous good tolerance and oth...
TRO19622 is an investigational small molecule being studied for Amyotrophic Lateral Sclerosis (ALS) and Non-Alcoholic Steatohepatitis (NASH). It has been evaluated in Phase 2 clinical trials for both conditions, though it remains in clinical development and is not approved.
TRO19622 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug in patients with ALS and NASH.
TRO19622 is in Phase 2 clinical development. It has completed Phase 2 trials for both ALS and NASH, but it is still investigational and has not been approved by regulatory authorities.
TRO19622 has been studied in two completed Phase 2 trials: NCT00666016, a short-term study in 22 patients with NASH in France, and NCT01285583, a safety extension study in 271 patients with ALS across Belgium, France, Germany, Spain, and the United Kingdom.
TRO19622 is also known as olesoxime. The drug has been investigated under the name TRO19622 in clinical trials for ALS and NASH, and the alternative name olesoxime is sometimes used to refer to the same compound.