Overview
A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from prostaglandin endoperoxides in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension.
Indication
For the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.
Associated Conditions
- Pulmonary Arterial Hypertension (PAH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/07/08 | Phase 2 | Not yet recruiting | Montreal Heart Institute | ||
2022/06/22 | Phase 1 | Completed | Actelion | ||
2020/10/20 | Phase 1 | UNKNOWN | |||
2020/06/30 | Phase 2 | Completed | |||
2016/04/22 | Phase 4 | Completed | |||
2016/03/11 | Phase 4 | Completed | |||
2014/09/26 | Phase 2 | Completed | |||
2012/10/30 | Phase 4 | Completed | |||
2011/11/11 | Phase 3 | Completed | Actelion | ||
2011/10/05 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GlaxoSmithKline LLC | 0173-0517 | INTRAVENOUS | 0.5 mg in 1 1 | 8/24/2021 | |
| Sun Pharmaceutical Industries, Inc. | 62756-059 | INTRAVENOUS | 0.5 mg in 10 mL | 1/16/2021 | |
| Actelion Pharmaceuticals US, Inc. | 66215-403 | INTRAVENOUS | 0.5 mg in 10 mL | 7/31/2022 | |
| Sun Pharmaceutical Industries, Inc. | 62756-060 | INTRAVENOUS | 1.5 mg in 10 mL | 1/16/2021 | |
| Actelion Pharmaceuticals US, Inc. | 66215-402 | INTRAVENOUS | 1.5 mg in 10 mL | 7/31/2022 | |
| GlaxoSmithKline LLC | 0173-0519 | INTRAVENOUS | 1.5 mg in 1 1 | 8/24/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VELETRI POWDER FOR SOLUTION FOR INFUSION 1.5MG/VIAL | SIN15406P | INJECTION, POWDER, FOR SOLUTION | 1.5mg | 1/11/2018 | |
| FLOLAN FOR INFUSION 0.5 mg/vial | SIN02241P | INJECTION, POWDER, FOR SOLUTION | 0.5 mg/vial | 7/4/1988 | |
| VELETRI POWDER FOR SOLUTION FOR INFUSION 0.5MG/VIAL | SIN15405P | INJECTION, POWDER, FOR SOLUTION | 0.5mg | 1/11/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VELETRI POWDER FOR SOLUTION FOR INFUSION 1.5MG/VIAL | N/A | N/A | N/A | 12/24/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial | 207547 | Medicine | A | 2/28/2014 | |
| EPOPROSTENOL SUN epoprostenol (as sodium) 1.5 mg powder for injection vial | 292847 | Medicine | A | 7/13/2018 | |
| VELETRI epoprostenol (as sodium) 500 microgram powder for injection vial | 208316 | Medicine | A | 2/28/2014 | |
| EPOPROSTENOL SUN epoprostenol (as sodium) 500 microgram powder for injection vial | 292849 | Medicine | A | 7/13/2018 |
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