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Also known as inhaled mosliciguat
Mosliciguat · 3 trials · 8 indications
PVR evaluated using right heart catheterization (RHC).
Absolute bioavailability of inhaled mosliciguat
Urine and fecal recovery of total \[14C\] radioactivity, \[14C\]-mosliciguat
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Mosliciguat (RVT-2301) | EXPERIMENTAL | Mosliciguat administered daily via dry powder inhaler. |
| 14C mosliciguat | EXPERIMENTAL | Administered orally and via IV |
| Name | Type | Description |
|---|---|---|
| inhaled mosliciguat | DRUG | Dose level 1, 2, or 3 for inhalation |
| Dry Powder Inhaler | DEVICE | Dry powder inhaler for mosliciguat delivery |
| Mosliciguat | DRUG | Dose level 1, 2, or 3 for inhalation |
| Placebo | DRUG | Matching placebo for inhalation |
| 14C mosliciguat | DRUG | Dose level |
Inclusion Criteria: * Participants willing and able to provide informed consent * Participants on inhaled treprostinil * Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal ...
| 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 |
Mosliciguat is an investigational small molecule being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD). It is also studied in healthy volunteers for early-phase safety assessment. The drug is inhaled and has received orphan drug designation from the FDA.
Mosliciguat is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker ROIV. The company is conducting clinical trials of the drug in the United States for pulmonary hypertension associated with interstitial lung disease.
Mosliciguat is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy adult males has been completed, and two Phase 2 studies in patients with pulmonary hypertension and interstitial lung disease are ongoing or recruiting. It is investigational and not yet approved.
Mosliciguat has three clinical trials: NCT06635850, a Phase 2 study in PH-ILD with 135 participants, active but not recruiting; NCT07185321, a completed Phase 1 study in healthy males with 8 participants; and NCT07333183, a recruiting Phase 2 study combining Mosliciguat with inhaled treprostinil in PH-ILD with 20 participants.
Yes, Mosliciguat is also known as inhaled mosliciguat, reflecting its route of administration. The drug is delivered via inhalation for the treatment of pulmonary hypertension associated with interstitial lung disease. It is a small molecule and has been granted orphan drug designation.
Yes, Mosliciguat has received orphan drug designation from the FDA. This designation is granted to drugs intended for the treatment of rare diseases and may provide benefits such as market exclusivity and development incentives. The drug is being studied for pulmonary hypertension associated with interstitial lung disease.