Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lloprost · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| I-Neb - FOX | EXPERIMENTAL | Part 1: Subjects received single inhalation of 1.25 mcg iloprost using 10 mcg/ml iloprost solution (Ventavis 10) and then 2.5 mcg iloprost using Ventavis 10, both using the FOX nebulizer on Day 1. Part 2: On Day 2, subjects received single inhalation of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer; followed by single inhalation of 5 mcg iloprost using 20 mcg/ml iloprost solution (Ventavis 20) with the FOX nebulizer in a cross-over fashion. A washout period of at least 2 hours was maintained between treatments in Part 1 and Part 2. Part 3: Continued on Day 2, and through until Day 30, subjects received multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer for 2 weeks; followed by multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 20 with the FOX nebulizer for 2 weeks in a cross-over fashion. |
| FOX - I-Neb | EXPERIMENTAL | Part 1: Subjects received single inhalation of 1.25 mcg iloprost using 10 mcg/ml iloprost solution (Ventavis 10) and then 2.5 mcg iloprost using Ventavis 10, both using the FOX nebulizer on Day 1. Part 2: On Day 2, subjects received single inhalation of 5 mcg iloprost using 20 mcg/ml iloprost solution (Ventavis 20) with the FOX nebulizer; followed by single inhalation of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer in a cross-over fashion. A wash-out period of at least 2 hours was maintained between treatments in Part 1 and Part 2. Part 3: Continued on Day 2, and through until Day 30, subjects received multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 20 with the FOX nebulizer for 2 weeks; followed by multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer for 2 weeks in a cross-over fashion. |
| Name | Type | Description |
|---|---|---|
| lloprost(Ventavis,BAYQ6252, 20 µg/mL) | DRUG | 20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer |
| lloprost(Ventavis,BAYQ6252, 10 µg/mL) | DRUG | 10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer |
Inclusion Criteria: * Male or female aged ≥ 18 years * Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1). * Current inhalative therapy with 5 µg iloprost using the I-Neb nebulizer * WHO functional class III at the time of the patient's commencement of inhalative ther...
| 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 |
lloprost is an investigational small molecule being developed for Pulmonary Arterial Hypertension (PAH), a form of high blood pressure in the arteries of the lungs. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
lloprost is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market.
lloprost is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for use in patients. One Phase 1 trial has been completed, and no active trials are currently listed.
lloprost has one completed Phase 1 clinical trial, identified as NCT02032836. This trial, titled 'Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)', enrolled 27 participants with Pulmonary Arterial Hypertension in Austria and Germany.
No, lloprost is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Pulmonary Arterial Hypertension. The drug has not completed the clinical trials necessary to establish safety and efficacy for regulatory approval.