Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Treprostinil Diolamine · 1 trial · 1 indication
Clinical worsening was assessed continuously from randomization until the subject's last study visit. Clinical worsening events were defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH, disease progression, or unsatisfactory long-term clinical response. All clinical worsening events reported by the study sites were reviewed by the Sponsor Medical Monitors. Once a clinical worsening event occurred, it was entered in the eCRF and a narrative was submitted for review by the Sponsor's Medical Monitor within 48 hours after the event became known to the Investigator or designee. Subsequently, the narratives for subjects with the reported clinical worsening events were sent to an independent adjudication committee. The independent adjudication committee reviewed and adjudicated all clinical worsening events throughout the study.
| Arm | Type | Description |
|---|---|---|
| UT-15C | EXPERIMENTAL | Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg TID |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets (oral) |
| Name | Type | Description |
|---|---|---|
| Treprostinil Diolamine | DRUG | Active |
| Placebo | DRUG | Placebo |
Subject Inclusion Criteria: 1. Voluntarily gave informed consent to participate in the study. 2. Are 18 to 75 years of age (inclusive) at Screening. 3. Women of childbearing potential must practice abstinence from intercourse when in line with their preferred and usual lifestyle, or use 2 different...
| 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 |
Treprostinil Diolamine is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Treprostinil Diolamine is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR.
Treprostinil Diolamine is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication.
Treprostinil Diolamine has one completed Phase 3 trial, NCT01560624, which studied the drug in subjects with Pulmonary Arterial Hypertension receiving background oral monotherapy. The trial enrolled 690 participants across multiple countries.
Treprostinil Diolamine is the drug being studied in the Phase 3 trial NCT01560624, which is titled 'Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy.' The trial refers to the drug as UT-15C.