Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Remodulin is a prostacyclin mimetic indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue… FDA label
Also known as Treprostinil Inhalation Powder
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 ...
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 |
Treprostinil is being developed for the treatment of pulmonary arterial hypertension, a condition involving high blood pressure in the arteries of the lungs. The inhalation powder formulation is designed to deliver the drug directly to the lungs. It is currently in Phase 1 clinical development.
Treprostinil targets PTGIR, the prostacyclin receptor. It acts as an agonist at this receptor. Activation of PTGIR leads to vasodilation and inhibition of platelet aggregation, which are relevant effects in pulmonary arterial hypertension.
MannKind Corporation, which trades on the Nasdaq under the ticker MNKD, is developing treprostinil inhalation powder. The company is responsible for the clinical development program in pulmonary arterial hypertension.
Treprostinil inhalation powder is in Phase 1 clinical development. It has not been approved by the FDA for any indication. The completed Phase 1 trial evaluated pharmacokinetics, safety, and tolerability in healthy volunteers.
Treprostinil inhalation powder has been studied in one completed Phase 1 trial, NCT03464864. The trial enrolled 36 healthy adult volunteers in the United States and assessed pharmacokinetics, safety, and tolerability. It was a controlled study without randomization or double blinding.
Yes, treprostinil inhalation powder is an inhaled formulation of treprostinil. The active ingredient is treprostinil, a small molecule prostacyclin receptor agonist. The inhalation powder is the specific dosage form being developed by MannKind Corporation.