Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACT-064992 · 1 trial · 1 indication
FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient's measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.
| Arm | Type | Description |
|---|---|---|
| ACT-064922 | EXPERIMENTAL | ACT-064922 tablet (macitentan), 10 mg, once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, once daily |
| Name | Type | Description |
|---|---|---|
| ACT-064992 (macitentan) | DRUG | ACT-064992 (macitentan) tablet, 10 mg, once daily |
| Placebo | DRUG | matching placebo, once daily |
Inclusion Criteria: 1. Signed informed consent. 2. Male or female patients of at least 18 years of age (females of child-bearing potential must use a reliable method of contraception). 3. IPF diagnosis within 3 years prior to randomization, proven according to the American Thoracic Society/European...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
ACT-064992 is an investigational small molecule being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ACT-064992 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential effects in Idiopathic Pulmonary Fibrosis, though the exact mechanism of action is not specified.
ACT-064992 is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research on this drug for Idiopathic Pulmonary Fibrosis.
ACT-064992 is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The drug is being studied for the treatment of Idiopathic Pulmonary Fibrosis, with one completed Phase 2 clinical trial.
ACT-064992 has been studied in one clinical trial, NCT00903331, titled "Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study." This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 178 participants with Idiopathic Pulmonary Fibrosis and has been completed.
ACT-064992 is also known as macitentan. The clinical trial NCT00903331, which studied this drug, is titled "Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study," confirming that ACT-064992 and macitentan refer to the same compound.