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 |
|---|---|---|---|---|---|
2025/08/11 | Not Applicable | Not yet recruiting | |||
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 |
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 | ||
Authorised | 4/3/2020 | ||
Authorised | 4/3/2020 | ||
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TREPROSTINILO DR REDDYS 2,5 MG/ML SOLUCION PARA PERFUSION EFG | Reddy Pharma Iberia S.A. | 84985 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| TRESUVI 2,5 MG/ML SOLUCION PARA PERFUSION EFG | Amomed Pharma Gmbh | 84772 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| TREPROSTINILO DR REDDYS 10 MG/ML SOLUCION PARA PERFUSION EFG | Reddy Pharma Iberia S.A. | 84983 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| TRESUVI 1 MG/ML SOLUCION PARA PERFUSION EFG | Amomed Pharma Gmbh | 84771 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| TREPROSTINILO ZENTIVA 10 MG/ML SOLUCION PARA PERFUSION EFG | 88060 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| TRESUVI 5 MG/ML SOLUCION PARA PERFUSION EFG | Amomed Pharma Gmbh | 84773 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| TREPROSTINILO FERRER 5 MG/ML SOLUCION PARA PERFUSION EFG | 83748 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| TREPROSTINILO ZENTIVA 2,5 MG/ML SOLUCION PARA PERFUSION EFG | 88062 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| TREPROSTINILO FERRER 1 MG/ML SOLUCION PARA PERFUSION EFG | 83745 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| TREPROSTINILO ZENTIVA 5 MG/ML SOLUCION PARA PERFUSION EFG | 88063 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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