> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/treprostinil-002fe1ce-a63f-4f2b-9562-6cbff048a970 > Record changed: 2026-11-04 # Treprostinil Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) First approval year 2002 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) ## Development status **First approval year** 2002 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **Drug name** Treprostinil Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **Molecular weight** 390.52 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **Structure (SMILES)** CCCCC\[C@H\](O)CC\[C@@H\]1\[C@H\]2Cc3cccc(OCC(=O)O)c3C\[C@H\]2C\[C@H\]1O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) ### Brand names (6) - remodulin - Remodulin - tyvaso - Tyvaso - tyvaso dpi - Tyvaso dpi ### Other names (47) - \[(1R,2R,3aS,9aS)-2-Hydroxy-1-((3S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cylopent\[b\]naphthalen-5-yl\]oxy\]acetate - 15 au 81 - 15-AU-81 - 15au81 - 15AU81 - 1r 2r 3as 9as 2 hydroxy 1 3s 3 hydroxyoctyl 2 3 3a 4 9 9a hexahydro 1h cylopent b naphthalen 5 yl oxy acetate - iv remodulin - IV Remodulin - l 606 - L-606 - l606 - L606 - LRX -15 - lrx 15 - LRX-15 - remodulin - Remodulin - rumodolin - Rumodolin - treprostinil - Treprostinil - treprostinil \[INN\] - TREPROSTINIL \[JAN\] - TREPROSTINIL \[MART.\] - TREPROSTINIL \[MI\] And 22 more, listed on the interactive page. ## Identifiers **ATC classification codes** - B01AC21 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **CAS registry numbers** - 81846-19-7 **ChEMBL ID** CHEMBL1237119 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **InChIKey** PAJMKGZZBBTTOY-ZFORQUDYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237119) **PubChem compound IDs** - 6918140 **RxNorm IDs (RxCUI)** - 343048 **FDA ingredient codes (UNII)** - RUM6K67ESG ## Regulatory information ### United States **Applicant** UNITED THERAP **Approval date** 21 May 2002 **Application number** NDA021272 ### European Union **Status** Authorised **Status date** 3 Apr 2020 **Authorisation date** 3 Apr 2020 **Approved indications** Treatment of adult patients with WHO Functional Class (FC) III or IV and: inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity. **Product number** EMEA/H/C/005207 **Authorisation holder** SciPharm Sàrl **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Hypertension, Pulmonary European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/trepulmix) ### Other regulatory facts **Patents** 18 **Designations** 2 **Earliest recorded loss of exclusivity** 3 Feb 2042 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** Yes **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Approval status **United States (FDA)** Approved **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** treprostinil **Type** Synthetic organic **Drug name stem** \-prost- **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral - topical ### Mechanisms of action (9) - **Action** Agonist **Action type** Agonist **Target** EP4 receptor **Gene symbol** PTGER4 **Protein identifier** P35408 **Median affinity** 6.7 **Affinity units** pEC50 - **Action** Agonist **Action type** Agonist **Target** EP4 receptor **Gene symbol** PTGER4 **Protein identifier** P35408 **Median affinity** 6.1 **Affinity units** pKi - **Mechanism** Prostanoid IP receptor agonist **Action type** Agonist **Target** Prostacyclin receptor **Protein identifier** P43119 - **Action** Full agonist **Action type** FULL\_AGONIST **Target** EP1 receptor **Gene symbol** PTGER1 **Protein identifier** P34995 **Median affinity** 6.7 **Affinity units** pKi - **Action** Full agonist **Action type** FULL\_AGONIST **Target** EP3 receptor **Gene symbol** PTGER3 **Protein identifier** P43115 **Median affinity** 5.6 **Affinity units** pKi - **Action** Full agonist **Action type** FULL\_AGONIST **Target** EP2 receptor **Gene symbol** PTGER2 **Protein identifier** P43116 **Median affinity** 8.4 **Affinity units** pKi - **Action** Full agonist **Action type** FULL\_AGONIST **Target** IP receptor **Gene symbol** PTGIR **Protein identifier** P43119 **Median affinity** 8.72 **Affinity units** pEC50 **Primary target** Yes - **Action** Full agonist **Action type** FULL\_AGONIST **Target** IP receptor **Gene symbol** PTGIR **Protein identifier** P43119 **Median affinity** 7.49 **Affinity units** pKi **Primary target** Yes - **Action** Full agonist **Action type** FULL\_AGONIST **Target** DP1 receptor **Gene symbol** PTGDR **Protein identifier** Q13258 **Median affinity** 8.4 **Affinity units** pKi ### Open Targets mechanisms - **Mechanism** Prostanoid IP receptor agonist **Action type** Agonist **Target** Prostacyclin receptor ### DrugCentral mechanisms (6) - **Action type** Agonist **Gene symbol** PTGER1 **Protein identifier** P34995 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Agonist **Gene symbol** PTGER4 **Protein identifier** P35408 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Agonist **Gene symbol** PTGER3 **Protein identifier** P43115 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Agonist **Gene symbol** PTGER2 **Protein identifier** P43116 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Agonist **Gene symbol** PTGIR **Protein identifier** P43119 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Agonist **Gene symbol** PTGDR **Protein identifier** Q13258 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (19) - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 2 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Ischemia **Highest recorded phase** 2 **Condition identifier** EFO:0000556 **Subject identifier** D007511 - **Condition** Scleroderma, Systemic **Highest recorded phase** 1 **Condition identifier** EFO:0000717 **Subject identifier** D012595 - **Condition** Idiopathic Pulmonary Fibrosis **Highest recorded phase** 3 **Condition identifier** EFO:0000768 **Subject identifier** D054990 - **Condition** Pulmonary Arterial Hypertension **Highest recorded phase** 4 **Condition identifier** EFO:0001361 **Subject identifier** D000081029 - **Condition** Hypertension, Pulmonary **Highest recorded phase** 4 **Condition identifier** EFO:0001361 **Subject identifier** D006976 - **Condition** Reperfusion Injury **Highest recorded phase** 1 **Condition identifier** EFO:0002687 **Subject identifier** D015427 - **Condition** Peripheral Vascular Diseases **Highest recorded phase** 2 **Condition identifier** EFO:0003875 **Subject identifier** D016491 - **Condition** Lung Diseases, Interstitial **Highest recorded phase** 3 **Condition identifier** EFO:0004244 **Subject identifier** D017563 - **Condition** Hernias, Diaphragmatic, Congenital **Highest recorded phase** 2 **Condition identifier** EFO:0005207 **Subject identifier** D065630 - **Condition** Pulmonary Fibrosis **Highest recorded phase** 3 **Condition identifier** EFO:0009448 **Subject identifier** D011658 - **Condition** Persistent Fetal Circulation Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:1001103 **Subject identifier** D010547 - **Condition** Raynaud Disease **Highest recorded phase** 0.5 **Condition identifier** EFO:1001145 **Subject identifier** D011928 - **Condition** Diabetic Foot **Highest recorded phase** 1 **Condition identifier** EFO:1001459 **Subject identifier** D017719 - **Condition** Thrombosis **Highest recorded phase** 4 **Condition identifier** HP:0004419 **Subject identifier** D013927 - **Condition** Familial Primary Pulmonary Hypertension **Highest recorded phase** 3 **Condition identifier** MONDO:0001999 **Subject identifier** D065627 - **Condition** Diabetes Mellitus, Type 1 **Highest recorded phase** 1 **Condition identifier** MONDO:0005147 **Subject identifier** D003922 - **Condition** Hypertension, Pulmonary **Highest recorded phase** 4 **Condition identifier** MONDO:0005149 **Subject identifier** D006976 - **Condition** Respiratory Distress Syndrome **Highest recorded phase** 2 **Condition identifier** MONDO:0100130 **Subject identifier** D012128 ### Open Targets indications (35) - **Condition identifier** EFO\_0000341 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000556 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000717 - **Condition identifier** EFO\_0000768 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001361 - **Condition identifier** EFO\_0002687 - **Condition identifier** EFO\_0003837 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003875 - **Condition identifier** EFO\_0004244 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005207 **Highest recorded phase** 2 - **Condition identifier** EFO\_0009197 - **Condition identifier** EFO\_0009448 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001103 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001145 - **Condition identifier** EFO\_1001459 - **Condition identifier** EFO\_1001459 **Highest recorded phase** 1 - **Condition identifier** HP\_0001750 - **Condition identifier** HP\_0003546 **Highest recorded phase** 2 - **Condition identifier** HP\_0004419 - **Condition identifier** HP\_0004419 **Highest recorded phase** 4 - **Condition identifier** HP\_0012418 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001999 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002123 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002771 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005002 **Highest recorded phase** 2 And 10 more, listed on the interactive page. ### Reported adverse events (60) - **Event** abdominal discomfort **Reports** 444 **Reporting signal score** 277.472 - **Event** abdominal distension **Reports** 339 **Reporting signal score** 253.235 - **Event** ascites **Reports** 225 **Reporting signal score** 234.468 - **Event** blood pressure decreased **Reports** 373 **Reporting signal score** 357.478 - **Event** chest discomfort **Reports** 399 **Reporting signal score** 259.354 - **Event** chest pain **Reports** 950 **Reporting signal score** 805.829 - **Event** cough **Reports** 1,276 **Reporting signal score** 1,124.88 - **Event** decreased appetite **Reports** 577 **Reporting signal score** 280.216 - **Event** dermatitis contact **Reports** 349 **Reporting signal score** 927.188 - **Event** device infusion issue **Reports** 110 **Reporting signal score** 341.441 - **Event** diarrhoea **Reports** 2,292 **Reporting signal score** 1,455.42 - **Event** dizziness **Reports** 1,449 **Reporting signal score** 723.491 - **Event** dyspnoea **Reports** 3,508 **Reporting signal score** 3,879.55 - **Event** dyspnoea exertional **Reports** 649 **Reporting signal score** 1,215.25 - **Event** epistaxis **Reports** 328 **Reporting signal score** 227.463 - **Event** fatigue **Reports** 1,411 **Reporting signal score** 347.503 - **Event** feeling abnormal **Reports** 571 **Reporting signal score** 354.571 - **Event** fluid overload **Reports** 599 **Reporting signal score** 1,595.15 - **Event** fluid retention **Reports** 879 **Reporting signal score** 1,816.54 - **Event** flushing **Reports** 765 **Reporting signal score** 1,019.68 - **Event** haemoptysis **Reports** 204 **Reporting signal score** 219.695 - **Event** headache **Reports** 2,715 **Reporting signal score** 2,375.28 - **Event** heart rate increased **Reports** 353 **Reporting signal score** 296.432 - **Event** hypotension **Reports** 925 **Reporting signal score** 534.583 - **Event** hypoxia **Reports** 337 **Reporting signal score** 404.381 And 35 more, listed on the interactive page. ### Trial references (53) - NCT00004497 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004497) - NCT00147199 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00147199) - NCT00325403 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00325403) - NCT00325442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00325442) - NCT00760916 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00760916) - NCT00887978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00887978) - NCT01104870 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01104870) - NCT03496623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03496623) - NCT05176951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05176951) - NCT00067041 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00067041) - NCT00439946 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00439946) - NCT00494533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00494533) - NCT00741819 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00741819) - NCT01027949 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01027949) - NCT01268553 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01268553) - NCT01305252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01305252) - NCT01477333 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01477333) - NCT01557647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01557647) - NCT01557660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01557660) - NCT01588405 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01588405) - NCT01615627 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01615627) - NCT01934582 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01934582) - NCT02882126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02882126) - NCT02893995 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02893995) - NCT02999906 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02999906) And 28 more, listed on the interactive page. ## Dosing **Dose** 18 mcg per treatment session (initial), titrating up to 9-12 breaths per session **Route** Inhalation **How often** 4 times daily approximately 4 hours apart during waking hours ### Conditions of use (3) - Administer undiluted - Do not mix with other medications in the device - Use only with the Tyvaso Inhalation System ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 3 **Polar surface area** 86.99 **Calculated partition coefficient (ALogP)** 3.58 **Calculated partition coefficient (XLogP)** 4.5 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 10 **Heavy atoms** 28 **Molecular formula** C23H34O5 **Monoisotopic mass** 390.24062418 **Natural product** Yes ## National Drug Codes - 0703-0666 - 0703-0676 - 0703-0686 - 0703-0696 - 0781-3420 - 0781-3425 - 0781-3427 - 0781-3430 - 0781-6021 - 43598-126 - 43598-646 - 43598-647 - 43598-648 - 43598-649 - 62332-514 - 62332-515 - 62332-516 - 62332-517 - 66302-101 - 66302-102 - 66302-105 - 66302-110 - 66302-114 - 66302-150 - 66302-206 And 26 more, listed on the interactive page. ## Evidence counts **Recorded assays** 117 **Active assays** 12 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Antihypertensive Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000959.html) ## Related records ### Trials (78) - A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil). - A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD) - A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD - A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD - A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension - A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus - A Study of Inhaled Treprostinil (LIQ861) in Adults With Pulmonary Arterial Hypertension Transitioning From Oral Selexipag - A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants - A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension - A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension - A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants - A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin - Acute Effects of Inhaled Treprostinil in Fontan Patients - ADAPT - A Patient Registry of the Real-world Use of Orenitram® - Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® - An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE - An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension - An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension - Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon - Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) ### Approved for (3) - Pulmonary arterial hypertension - [Pulmonary hypertension](https://trialight.com/data/condition/pulmonary-hypertension-1e275435-e811-5e99-a8d1-abef649a72f4.md) - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) ### In development for (15) - [Adult acute respiratory distress syndrome](https://trialight.com/data/condition/adult-acute-respiratory-distress-syndrome-52101d99-65d3-54cf-b5da-f664febc6a7e.md) Phase 2 - Calcinosis Phase 2 - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 2 - Congenital heart disease Phase 2 - Idiopathic pulmonary arterial hypertension Phase 3 - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Phase 3 - [Interstitial lung disease](https://trialight.com/data/condition/interstitial-lung-disease-745f5770-ba0b-517d-b691-5b9731a03266.md) Phase 3 - Ischemia reperfusion injury Phase 1 - [Ischemic disease](https://trialight.com/data/condition/ischemic-disease-e392447f-9e7d-56b5-9762-6ebf75e589e2.md) Phase 2 - Peripheral vascular disease Phase 2 - Persistent fetal circulation syndrome Phase 2 - [Pulmonary fibrosis](https://trialight.com/data/condition/pulmonary-fibrosis-bc07081b-8a87-523b-80ff-c58435a000f3.md) Phase 3 - Raynaud disease Early phase 1 - [Systemic sclerosis](https://trialight.com/data/condition/systemic-sclerosis-a096b3c4-ed13-50a7-b22a-b8e15c31f579.md) Phase 1 - [Type 1 diabetes mellitus](https://trialight.com/data/condition/type-1-diabetes-mellitus-c22c640e-5db9-525c-8e4b-8da31250a7a3.md) Phase 1 ### Targets (6) - [PTGDR](https://trialight.com/data/target/ptgdr-e1fcfe16-9707-5c06-8ea9-af422cd94cd4.md) - [PTGER1](https://trialight.com/data/target/ptger1-bf966316-397d-594e-b09a-c53320112887.md) - [PTGER2](https://trialight.com/data/target/ptger2-cb9b3c14-5b7f-5eb3-963b-5a2c095b85d1.md) - [PTGER3](https://trialight.com/data/target/ptger3-eaa7b5e5-6757-5f68-b82e-5975080209f6.md) - [PTGER4](https://trialight.com/data/target/ptger4-9f54f68f-da8d-5c48-8282-f46107d5b5a3.md) - [PTGIR](https://trialight.com/data/target/ptgir-163aa702-ffc9-5c67-bd29-a5074c10565d.md) Prostanoid IP receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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