Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN13335 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| DBTP-Arm1 | EXPERIMENTAL | - |
| DBTP-Arm2 | EXPERIMENTAL | - |
| DBTP-Arm3 | PLACEBO_COMPARATOR | - |
| OLE-Arm1 | EXPERIMENTAL | - |
| OLE-Arm2 | EXPERIMENTAL | - |
| IV Cohort 1 Low Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 2 Mid Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 3 High Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 4 Higher Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 5 Highest Dose | EXPERIMENTAL | Randomized as described in the protocol |
| SC Cohort 1 Low Dose | EXPERIMENTAL | Randomized as described in the protocol |
| SC Cohort 2 High Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV or SC Optional Cohort | EXPERIMENTAL | ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol |
| Name | Type | Description |
|---|---|---|
| REGN13335 | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
| Matching Placebo | DRUG | Administered IV or SC, sequential ascending single dose |
Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. Receiving background Standard Of Care (SOC) therapy f...
| 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 |
REGN13335 is an investigational small molecule being developed by Regeneron Pharmaceuticals for the treatment of Pulmonary Arterial Hypertension (PAH). It is also being studied in healthy volunteers to assess its safety and tolerability. The drug is administered either intravenously or subcutaneously and is currently in clinical development.
REGN13335 is a small molecule therapeutic being developed by Regeneron Pharmaceuticals for Pulmonary Arterial Hypertension (PAH). The specific molecular target of REGN13335 has not been disclosed in available information. The drug is administered intravenously or subcutaneously and is currently being evaluated in clinical trials.
REGN13335 is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy volunteers and in patients with Pulmonary Arterial Hypertension (PAH).
REGN13335 is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy volunteers has been completed, and a Phase 2 study in patients with Pulmonary Arterial Hypertension (PAH) is currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities.
REGN13335 is being studied in two clinical trials. NCT06137482 is a completed Phase 1 study in healthy volunteers in New Zealand. NCT07318597 is a recruiting Phase 2 study in patients with Pulmonary Arterial Hypertension (PAH) across multiple countries, including the United States, Australia, and several European and Asian nations.
REGN13335 is the sole name provided for this investigational drug developed by Regeneron Pharmaceuticals. No alternative names or aliases have been associated with REGN13335 in the available information. It is being studied for Pulmonary Arterial Hypertension (PAH) and in healthy volunteers.