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ACT-293987 · 2 trials · 1 indication
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ACT-293987, twice daily |
| ACT-293987 (NS-304) and matching placebo | EXPERIMENTAL | Subjects will be randomized to the study following screening. Each subject will then undergo an acute hemodynamic study with right heart catheterization after a single oral administration of ACT-293987 (NS-304)on Day 0. The objectives are to collect data about the drug effect on the right heart hemodynamic parameters (PVR, calculated SVR and PVR/SVR) measured by right heart catheterization after single oral dose administration of NS-304 and to assess the safety and tolerability of a single oral dose of NS-304. |
| Name | Type | Description |
|---|---|---|
| ACT-293987 | DRUG | Tablets, twice daily |
| ACT-293987 (NS-304) | DEVICE | - |
Inclusion Criteria: * Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol. * Signed informed consent. Exclusion Criteria: * Patients who have started receiving prostacyclin (epoprostenol) or prostacyc...
| 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 |
ACT-293987 is an investigational drug being studied for the treatment of Pulmonary Arterial Hypertension (PAH), a type of high blood pressure affecting the arteries in the lungs and the right side of the heart. It is being developed by Johnson & Johnson (JNJ) and is currently in Phase 3 clinical development.
ACT-293987 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 3 clinical trials for the treatment of Pulmonary Arterial Hypertension.
ACT-293987 is in Phase 3 clinical development for Pulmonary Arterial Hypertension. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy. Two clinical trials have been completed, including a Phase 3 study.
ACT-293987 has been studied in two completed clinical trials. NCT00993408 was a Phase 2 study with 43 participants, and NCT01112306 was a Phase 3 study with 709 participants. Both trials focused on Pulmonary Arterial Hypertension and enrolled adults aged 18 years and older.
ACT-293987 is also known as NS-304, as indicated in the title of the Phase 2 clinical trial NCT00993408, which refers to the drug as ACT-293987 (NS-304). Both names refer to the same investigational compound being developed for Pulmonary Arterial Hypertension.