Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Treprostinil · 1 trial · 1 indication
Incidence and severity of treatment-related adverse events determined by changes from screening (baseline) of findings from physical examinations, laboratory evaluations, vital signs measurements, pulmonary testing, and ECG measurements.
| Arm | Type | Description |
|---|---|---|
| Treprostinil Inhalation Powder 30 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 60 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 90 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 120 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 150 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 180 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 240 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 300 mcg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Treprostinil Inhalation Powder | DRUG | Single ascending dose |
Inclusion Criteria: 1. Voluntarily consents to participate in this study and provides written informed consent prior to the start of any study-specific procedures. 2. Male or female. Females must not be pregnant or breastfeeding. 3. Is between 18 and 55 years of age (inclusive). 4. Female subjects ...
| 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 is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH), a type of high blood pressure affecting the arteries in the lungs. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.
Treprostinil is being developed by MannKind Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the drug's pharmacokinetics, safety, and tolerability in patients with Pulmonary Arterial Hypertension.
Treprostinil is in Phase 1 clinical development. A Phase 1 trial has been completed, which focused on evaluating the drug's pharmacokinetics, safety, and tolerability in healthy volunteers. The drug is investigational and has not received FDA approval for any indication.
Treprostinil has one completed clinical trial registered under NCT03464864, titled "Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers." This Phase 1 study enrolled 36 participants in the United States and was a controlled, open-label trial involving healthy adults aged 18 years and older.
Treprostinil is a small molecule designed to treat Pulmonary Arterial Hypertension. While the specific molecular target is not disclosed, the drug is being developed as an inhalation powder intended to deliver the medication directly to the lungs, potentially improving local delivery and reducing systemic side effects compared to other routes of administration.