Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prostacyclin Receptor Agonist · 1 trial · 1 indication
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Serious TEAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.
Number of participants with TEAEs by severity will be evaluated. An assessment of severity grade will be made using the following general categorical descriptors, such as Mild (Awareness of symptoms that are easily tolerated, causing minimal discomfort, and not interfering with everyday activities), Moderate (Sufficient discomfort is present to cause interference with normal activity), and Severe (Extreme distress, causing significant impairment of functioning or incapacitation, and prevents normal everyday activities).
Number of participants with TEAEs leading to discontinuation will be reported.
Number of participants with change from baseline in clinical laboratory values (chemistry, hematology, and urinalysis) will be evaluated.
Number of participants with injection site reactions will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Prostacyclin Receptor Agonist | EXPERIMENTAL | Participants in Cohort 1-7 will receive multiple doses of prostacyclin receptor agonist of formulation 1 in treatment period 1, followed by a single dose of various other formulations (formulation 2, 3, and 4) in treatment period 2. Cohort 7 will be optional. Doses in Cohorts 4, 5, 6 and cohort 7 will be based on PK, safety and tolerability data of previous 3 cohorts (preceding cohorts). |
| Name | Type | Description |
|---|---|---|
| Prostacyclin Receptor Agonist | DRUG | Prostacyclin receptor agonist will be administered. |
Inclusion Criteria: * Otherwise, healthy as deemed by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECG) performed at Screening and Day -1 of oral treatment period * Otherwise, healthy medically stable on the basis of clinical l...
| 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 |
Prostacyclin Receptor Agonist is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in patients with PAH.
Prostacyclin Receptor Agonist is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug as a potential treatment for Pulmonary Arterial Hypertension. The drug is currently in Phase 1 development and remains investigational.
Prostacyclin Receptor Agonist is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug is being studied for the treatment of Pulmonary Arterial Hypertension.
Prostacyclin Receptor Agonist has one completed Phase 1 clinical trial, NCT05427162, titled 'A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist.' The trial enrolled 88 participants in the United States and included healthy volunteers, with a minimum age of 18 years.
Prostacyclin Receptor Agonist works by targeting the prostacyclin receptor, a G protein-coupled receptor involved in vasodilation and inhibition of platelet aggregation. By activating this receptor, the drug aims to dilate pulmonary arteries and reduce vascular resistance, which may benefit patients with Pulmonary Arterial Hypertension.