Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Iloprost Inhalation Solution (Ventavis), Ventavis
Iloprost · 4 trials · 4 indications
Number of adverse events
Number of serious adverse events
Number of adverse events leading to discontinuation of study treatment
Number of patients with adverse events leading to discontinuation of study treatment
The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk. It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization.
| Arm | Type | Description |
|---|---|---|
| iloprost power 6 | ACTIVE_COMPARATOR | iloprost power 15 |
| iloprost power 15 | EXPERIMENTAL | iloprost power 15 |
| Active / placebo | EXPERIMENTAL | Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 |
| Placebo / active | PLACEBO_COMPARATOR | Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3 |
| Name | Type | Description |
|---|---|---|
| iloprost | DRUG | Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study. |
| iloprost (5 µg) | DRUG | Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc |
| placebo | DRUG | Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc |
| Iloprost Inhalation Solution (Ventavis) | DRUG | - |
| Iloprost or placebo | DRUG | - |
Inclusion Criteria: 1. Signed informed consent prior to initiation of any study mandated procedure, 2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301, 3. Women of childbearing potential must have...
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 |
Iloprost is a small molecule drug developed by Johnson & Johnson (ticker JNJ) for rare disease indications, specifically pulmonary arterial hypertension and pulmonary fibrosis. It is administered as an inhalation solution and has been studied in Phase 3 clinical trials. Iloprost is also known as Iloprost Inhalation Solution (Ventavis).
Iloprost is used for the treatment of pulmonary arterial hypertension (PAH). It is also being studied in pulmonary fibrosis. Clinical trials have evaluated its safety and efficacy in adults with PAH, including a Phase 3 trial and a Phase 2 add-on therapy trial with bosentan.
Iloprost targets PTGIR, the prostacyclin receptor. It acts as an agonist at this receptor, which is a G-protein coupled receptor. This mechanism leads to vasodilation and inhibition of platelet aggregation, which is relevant in conditions like pulmonary arterial hypertension.
Iloprost is developed by Johnson & Johnson, which trades under the ticker symbol JNJ. Johnson & Johnson is a multinational pharmaceutical and medical devices company. The drug is part of their portfolio for rare diseases, specifically for pulmonary arterial hypertension.
Iloprost is in Phase 3 clinical development. It has completed three Phase 3 trials and one Phase 2 trial. The Phase 3 trials include the Iloprost Power 15 study and its safety extension, both in pulmonary arterial hypertension. The drug is investigational and not approved.
Iloprost has been studied in several clinical trials, including NCT00709956 (Phase 3, Iloprost Power 15 in PAH), NCT00709098 (Phase 3 safety extension), NCT00109681 (Phase 2 in pulmonary fibrosis and pulmonary hypertension), and NCT00086463 (Phase 2 add-on therapy with bosentan in PAH). All trials are completed.