Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rodatristat ethyl · 4 trials · 2 indications
Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC)
Measure Rodatristat, rodatristat ethyl, and its metabolite(s): Maximum plasma concentration Cmax, area under the plasma concentration-time curve from time zero (predose) to the last detectable time point.
Measure PK parameters, area under the concentration time curve over the dosing interval.
Measure change in baseline in QTcF
Assessments of adverse events
| 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 |
| Rodatristat ethyl | EXPERIMENTAL | Part One: is 600 QD |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Placebo for Rodatristat | PLACEBO_COMPARATOR | - |
| Placebo for Moxifloxacin | PLACEBO_COMPARATOR | - |
| Rodatristat Ethyl 300 mg BID - Japanese subjects | EXPERIMENTAL | - |
| Placebo match for Rodatristat Ethyl 300 mg BID - Japanese subjects | PLACEBO_COMPARATOR | - |
| Rodatristat Ethyl 300 mg BID - Caucasian subjects | EXPERIMENTAL | - |
| Placebo match for Rodatristat Ethyl 300 mg BID - Caucasian subjects | PLACEBO_COMPARATOR | - |
| Rodatristat Ethyl 600 mg BID - Japanese subjects | EXPERIMENTAL | - |
| Placebo match for Rodatristat Ethyl 600 mg BID - Japanese subjects | PLACEBO_COMPARATOR | - |
| Rodatristat Ethyl 600 mg BID - Caucasian subjects | EXPERIMENTAL | - |
| Placebo match for Rodatristat Ethyl 600 mg BID - Caucasian subjects | PLACEBO_COMPARATOR | - |
| 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 |
| Rodatristat Ethyl | DRUG | Tablets, Oral, 600mg, QD |
| Moxifloxacin | DRUG | Oral, Tablet, 400 mg QD |
| Placebo for Rodatristat | DRUG | Oral, Tablet, O mg QD, 0 mg BID |
| Placebo for Moxifloxacin | DRUG | Oral, Tablet, 0 mg QD |
| Rodatristat Ethyl 300 mg BID | DRUG | Tablets, oral, 300 mg, BID 14 days |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
Rodatristat Ethyl is an investigational small molecule being studied for pulmonary arterial hypertension (PAH) and in healthy volunteers for safety and tolerability trials. It is developed by Roivant Sciences Ltd. (ticker: ROIV) and is currently in Phase 1 clinical development, with completed trials including a Phase 2 study in PAH patients.
Rodatristat Ethyl is developed by Roivant Sciences Ltd., a biopharmaceutical company traded on the stock exchange under the ticker ROIV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in pulmonary arterial hypertension and in healthy subjects.
Rodatristat Ethyl is in Phase 1 clinical development. It has completed three trials, including a Phase 2 study in pulmonary arterial hypertension and multiple Phase 1 studies in healthy volunteers. The drug is investigational and not yet approved by regulatory authorities.
Rodatristat Ethyl has completed three trials: NCT04712669, a Phase 2 study in patients with pulmonary arterial hypertension; NCT05065359, a multiple-ascending dose bridging study in healthy Japanese subjects; and NCT05684640, a single and multiple dose study in healthy adults to evaluate food effects and safety. All trials are completed.
Rodatristat Ethyl is the ethyl ester prodrug form of Rodatristat. In the body, Rodatristat Ethyl is converted to Rodatristat and its major metabolites, which are the active compounds. Clinical trials evaluate the effects of both the prodrug and its metabolites on the heart and other safety parameters.