Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rodatristat Ethyl · 1 trial · 1 indication
Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC)
| Arm | Type | Description |
|---|---|---|
| Rodatristat Ethyl 300 mg BID | EXPERIMENTAL | MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks |
| Rodatristat Ethyl 600 mg BID | EXPERIMENTAL | MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks |
| Placebo-Rodatristat Ethyl 300 mg | EXPERIMENTAL | Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase |
| Placebo-Rodatristat Ethyl 600 mg | EXPERIMENTAL | Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase |
| Rodatristat Ethyl 300 mg-Rodatristat Ethyl 300 mg | EXPERIMENTAL | Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase |
| Rodatristat Ethyl 300 mg-Rodatristat Ethyl 600 mg | EXPERIMENTAL | Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase |
| Rodatristat Ethyl 600 mg-Rodatristat Ethyl 600 mg | EXPERIMENTAL | Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase |
| Name | Type | Description |
|---|---|---|
| rodatristat ethyl 300 mg tablet BID | DRUG | rodatristat ethyl 300 mg tablet + matching placebo tablet twice daily on top of standard of care |
| rodatristat ethyl 600 mg BID | DRUG | 2 rodatristat ethyl 300 mg tablets twice daily on top of standard of care |
| Placebo | DRUG | 2 matching placebo tablets on top of standard of care |
Inclusion Criteria: 1\. Male and female 18 years or older 2. Body Mass Index (BMI) \>18kg/m2 to \<=40kg/m2 3. Symptomatic PAH belonging to one of the following 2018 WHO Clinical Group 1 subtypes: a. Idiopathic PAH b. Heritable PAH c. Drug- or toxin-induced d. PAH associated with: 1. Connective ti...
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| Liquidia Corporation | LQDA | 4 | PHASE3 | L606, LIQ861 Treprostinil, LIQ861 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | Levosimendan (TNX-103) |
| Inhibikase Therapeutics, Inc. | IKT | 2 | PHASE3 | IKT-001 |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Tectonic Therapeutic Inc | TECX | 2 | PHASE2 | TX45 |
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| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
Rodatristat Ethyl is being developed for the treatment of pulmonary arterial hypertension, a cardiovascular condition. It is an investigational small molecule and is not yet approved for any indication. The clinical program has studied it in adults with pulmonary arterial hypertension.
Rodatristat Ethyl is a small molecule that targets the -stat enzyme class. By acting on this enzyme target, it is designed to affect the biological pathway involved in pulmonary arterial hypertension. The precise clinical effects of this mechanism are still being evaluated in clinical development.
Rodatristat Ethyl is being developed by Roivant Sciences Ltd., which trades under the ticker ROIV. The company is responsible for the clinical program evaluating the drug in pulmonary arterial hypertension.
Rodatristat Ethyl is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The Phase 2 program has been conducted in patients with pulmonary arterial hypertension.
Rodatristat Ethyl has been studied in one clinical trial, NCT04712669, titled A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE). This Phase 2 trial was completed and enrolled 108 participants across multiple countries including the United States, Canada, and several European nations.