Overview
Iloprost is a synthetic analogue of prostacyclin PGI2 that dilates systemic and pulmonary arterial vascular beds. It is used to treat pulmonary arterial hypertension (PAH).
Indication
Used for the treatment of pulmonary arterial hypertension.
Associated Conditions
- NYHA class III Pulmonary arterial hypertension
- NYHA class IV Pulmonary arterial hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/20 | Phase 2 | Recruiting | Pär Johansson | ||
2022/06/09 | Phase 2 | Withdrawn | |||
2020/10/22 | Not Applicable | UNKNOWN | |||
2020/10/12 | Not Applicable | UNKNOWN | |||
2020/09/10 | Phase 1 | Recruiting | |||
2020/06/24 | Phase 2 | Completed | |||
2020/06/09 | Phase 2 | Completed | Pär Johansson | ||
2019/10/11 | Phase 2 | Completed | Jakob Stensballe, MD, PhD | ||
2019/07/31 | Phase 3 | Completed | |||
2019/05/03 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. | 66215-303 | RESPIRATORY (INHALATION) | 20 ug in 1 mL | 3/9/2022 | |
| Actelion Pharmaceuticals US, Inc. | 66215-302 | RESPIRATORY (INHALATION) | 10 ug in 1 mL | 3/9/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/15/2003 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VENTAVIS SOLUTION FOR INHALATION | SIN13140P | SOLUTION | 0.010 mg/ml | 7/6/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Iloprost Solution for Inhalation | 国药准字HJ20140939 | 化学药品 | 吸入制剂 | 4/25/2023 | |
| Iloprost Solution for Inhalation | 国药准字HJ20140940 | 化学药品 | 吸入制剂 | 4/25/2023 | |
| Iloprost Solution for Inhalation | 国药准字HJ20140941 | 化学药品 | 吸入制剂 | 4/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VENTAVIS iloprost 10 microgram/mL solution for inhalation ampoule | 97219 | Medicine | A | 1/21/2004 |
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