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Also known as inhaled mosliciguat
Mosliciguat · 3 trials · 7 indications
The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes
PVR evaluated using right heart catheterization (RHC).
| Arm | Type | Description |
|---|---|---|
| Mosliciguat | ACTIVE_COMPARATOR | Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
| Matched Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
| Extension | EXPERIMENTAL | After Week 24, all participants may receive mosliciguat through an Extension period |
| Active Comparator: inhaled mosliciguat | EXPERIMENTAL | Participants will receive inhaled mosliciguat daily for 16 weeks |
| Extension: inhaled mosliciguat | EXPERIMENTAL | After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period |
| Name | Type | Description |
|---|---|---|
| Mosliciguat | DRUG | Dose level 1, 2, or 3 for inhalation |
| Placebo | DRUG | Matching Placebo for inhalation |
| Dry Powder Inhaler | DEVICE | Administration via dry powder inhaler |
| inhaled mosliciguat | DRUG | Dose level 1, 2, or 3 for inhalation |
Inclusion Criteria: * Participants willing and able to provide informed consent. * Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenc...
Top 13 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 8 | PHASE3 | Sotatercept, Riociguat, Frespaciguat |
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag, Tyvaso (treprostinil) |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | selexipag, Macitentan |
| 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 |
| Gossamer Bio, Inc. | GOSS | 1 | PHASE3 | Seralutinib |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
Mosliciguat is an inhaled small molecule being developed by Roivant Sciences Ltd. (ticker ROIV) for pulmonary hypertension. It is an investigational therapy in Phase 3 clinical development and has received an orphan drug designation from the FDA. It is also referred to as inhaled mosliciguat.
Mosliciguat is being studied for pulmonary hypertension, with the clinical program focused on pulmonary hypertension associated with interstitial lung disease, known as PH-ILD. The trials enroll adults with pulmonary hypertension, interstitial lung disease, and related vascular and cardiovascular conditions.
Mosliciguat is developed by Roivant Sciences Ltd., which trades under the ticker ROIV. The company is running the clinical program for the inhaled small molecule across pulmonary hypertension associated with interstitial lung disease.
Mosliciguat is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes the PHrontier trial, and earlier Phase 2 studies of the drug in PH-ILD are also part of the development effort.
Mosliciguat is being evaluated in three trials. The Phase 3 PHrontier trial (NCT07816185) is recruiting 376 patients. A Phase 2 combination study with inhaled treprostinil (NCT07333183) is recruiting 20 patients, and a Phase 2 PH-ILD study (NCT06635850) is active but not recruiting 135 patients.
Yes, inhaled mosliciguat is another name for mosliciguat. Both refer to the same investigational small molecule developed by Roivant Sciences Ltd. for pulmonary hypertension, delivered by inhalation and studied in pulmonary hypertension associated with interstitial lung disease.