Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ACT-293987
i.v. selexipag · 3 trials · 1 indication
AE is any untoward medical event that occurs in a participant during the course of the study whether or not considered by the investigator as related to the study treatment.
Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.
This is the number of participants with at least one clinically significant reaction at the injection site (e.g., erythema/redness, tenderness, swelling, induration, hemorrhage at the injection site) occurring on the days of intravenous (iv) selexipag injection.
This is the number of subjects who discontinued the i.v. selexipag treatment due to prostacyclin-associated adverse events (headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia).
This is the number of participants with at least one AE considered to be related to pulmonary arterial hypertension during the course of the study.
An adverse event (AE) 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. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
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. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.
An adverse event (AE) 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. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
| Arm | Type | Description |
|---|---|---|
| Selexipag | EXPERIMENTAL | Subjects with stable pulmonary arterial hypertension (PAH) and currently treated with a stable oral dose of Uptravi will be switched to i.v. selexipag from Day 2 to Day 3 (2 infusions on Day 2 and 1 infusion on Day 3). Otherwise, they will continue with their current oral selexipag treatment throughout the study. |
| 1 | EXPERIMENTAL | ACT-293987, twice daily |
| ACT-293987 (NS-304) and matching placebo | EXPERIMENTAL | Subjects will be randomized to the study following screening. Each subject will then undergo an acute hemodynamic study with right heart catheterization after a single oral administration of ACT-293987 (NS-304)on Day 0. The objectives are to collect data about the drug effect on the right heart hemodynamic parameters (PVR, calculated SVR and PVR/SVR) measured by right heart catheterization after single oral dose administration of NS-304 and to assess the safety and tolerability of a single oral dose of NS-304. |
| Name | Type | Description |
|---|---|---|
| i.v. selexipag | DRUG | Selexipag for intravenous administration, twice daily as an infusion over 87 min. The dose is individualized for each subject to correspond to his/her current oral dose of Uptravi®. |
| oral selexipag (Uptravi) | DRUG | Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information |
| ACT-293987 | DRUG | Tablets, twice daily |
| ACT-293987 (NS-304) | DEVICE | - |
Inclusion Criteria: * Signed informed consent form prior to any study-mandated procedure. * Male and female subjects aged from 18 to 75 years (inclusive), * Subjects with stable pulmonary arterial hypertension (PAH) defined as WHO Functional Class I-III at Visit 1 and Visit 2, and no change (i.e., ...
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 |
I.v. selexipag is used for pulmonary arterial hypertension (PAH). It is an investigational small molecule being developed by Johnson & Johnson (JNJ) as an intravenous formulation of selexipag, intended for patients with stable PAH. It is currently in Phase 3 clinical development.
I.v. selexipag is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is evaluating this intravenous formulation of selexipag for the treatment of pulmonary arterial hypertension.
I.v. selexipag is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 study has been completed to evaluate its safety in patients with stable pulmonary arterial hypertension.
I.v. selexipag has one completed Phase 3 clinical trial, NCT03187678, titled "Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension." The study enrolled 20 participants in the United States and Germany.
I.v. selexipag is an intravenous formulation of selexipag, which is also available as an oral medication. The Phase 3 trial NCT03187678 specifically studied switching from oral selexipag to intravenous selexipag in patients with stable pulmonary arterial hypertension.