Overview
Treprostinil is a stable tricyclic analogue of prostacyclin that promotes the vasodilation of pulmonary and systemic arterial vascular beds and the inhibition of platelet aggregation. It reduces symptoms in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The first agent approved for the treatment of PAH was epoprostenol, a synthetic prostacyclin that significantly increases patients' quality of life. However, the use of epoprostenol is limited due to its short half-life (3-5 min) and instability at room temperature. The use of more stable alternatives such as treprostinil provides patients with PAH with more treatment options. Treprostinil was approved by the FDA in 2002 for the treatment of pulmonary arterial hypertension. It is available in the following routes of administration: subcutaneous, intravenous, inhaled and oral. The first generic form of treprostinil became available in 2019.
Indication
The FDA has indicated treprostinil for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability. It is also used to treat pulmonary arterial hypertension in patients requiring transition from epoprostenol. The Health Canada label specifies that treprostinil is indicated for the long-term treatment of pulmonary arterial hypertension in NYHA Class III and IV patients who did not respond adequately to conventional therapy. L24244
Associated Conditions
- Pulmonary Arterial Hypertension (PAH)
- Pulmonary Hypertension (PH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/23 | N/A | AVAILABLE | |||
2024/09/19 | N/A | Not yet recruiting | |||
2024/04/05 | Phase 3 | Recruiting | |||
2024/01/05 | Phase 1 | Completed | |||
2023/10/19 | Phase 1 | Completed | |||
2023/07/13 | Phase 3 | Recruiting | |||
2022/12/14 | Phase 2 | Active, not recruiting | |||
2022/12/14 | Phase 2 | Active, not recruiting | |||
2022/10/10 | N/A | AVAILABLE | |||
2022/10/03 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| United Therapeutics Corporation | 66302-206 | ORAL | 1.74 mg in 2.9 mL | 5/6/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-517 | INTRAVENOUS, SUBCUTANEOUS | 200 mg in 20 mL | 7/5/2019 | |
| United Therapeutics Corporation | 66302-632 | ORAL | 32 ug in 1 1 | 11/30/2023 | |
| Teva Parenteral Medicines, Inc. | 0703-0696 | INTRAVENOUS, SUBCUTANEOUS | 200 mg in 20 mL | 5/1/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-515 | INTRAVENOUS, SUBCUTANEOUS | 50 mg in 20 mL | 7/5/2019 | |
| United Therapeutics Corporation | 66302-300 | ORAL | 0.125 mg in 1 1 | 8/9/2023 | |
| United Therapeutics Corporation | 66302-732 | ORAL | 32 ug in 1 1 | 11/30/2023 | |
| Sandoz Inc | 0781-3420 | SUBCUTANEOUS, INTRAVENOUS | 20 mg in 20 mL | 10/3/2018 | |
| United Therapeutics Corporation | 66302-748 | ORAL | 48 ug in 1 1 | 11/30/2023 | |
| Liquidia Technologies, Inc. | 72964-011 | RESPIRATORY (INHALATION) | 26.5 ug in 1 1 | 5/23/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/3/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Treprostinil Injection | 国药准字H20233266 | 化学药品 | 注射剂 | 3/15/2023 | |
| Treprostinil Injection | 国药准字H20203101 | 化学药品 | 注射剂 | 3/17/2020 | |
| Treprostinil Injection | 国药准字H20227027 | 化学药品 | 注射剂 | 3/9/2022 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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