Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Seralutinib · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Seralutinib 90 mg | EXPERIMENTAL | Seralutinib inhaled orally twice per day (BID) |
| Placebo | PLACEBO_COMPARATOR | Placebo inhaled orally twice daily (BID) up to 48 weeks |
| Name | Type | Description |
|---|---|---|
| Seralutinib | DRUG | Capsule containing seralutinib |
| Gereic Dry Powder Inhaler | DEVICE | Generic dry powder inhaler for seralutinib delivery |
| Placebo | DRUG | Matching capsule containing placebo |
| Generic Dry Powder Inhaler | DEVICE | Generic dry powder inhaler for seralutinib or placebo delivery |
Inclusion Criteria: 1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol. 2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been inform...
| 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 |
Seralutinib is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH) in adults. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in randomized, double-blind, placebo-controlled trials to assess its efficacy and safety in this patient population.
Seralutinib is a kinase inhibitor that targets PDGFRB, PDGFRA, CSF1R, and KIT. By inhibiting these molecular targets, it is designed to interfere with signaling pathways involved in the pathogenesis of Pulmonary Arterial Hypertension. This mechanism is being investigated in clinical trials to determine its therapeutic potential in PAH.
Seralutinib is being developed by Gossamer Bio, Inc., a biopharmaceutical company publicly traded under the ticker symbol GOSS. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with Pulmonary Arterial Hypertension.
Seralutinib is currently in Phase 3 clinical development for Pulmonary Arterial Hypertension. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials are associated with the program, one completed and one actively recruiting patients.
Seralutinib is being studied in two Phase 3 trials. The first, NCT05934526, is a completed study with 390 participants evaluating efficacy and safety in PAH. The second, NCT06274801, is an open-label extension study with 330 participants that is currently recruiting. Both trials enroll adults aged 18 years and older.
Yes, Seralutinib is identified by the ChEMBL identifier CHEMBL4650333. This identifier is used in chemical and pharmaceutical databases to reference the compound. In clinical trial registries and scientific literature, the drug is primarily referred to as Seralutinib.