Remodulin, Trepulmix(treprostinil)
Orenitram, Remodulin, Treprostinil, Trepulmix, Tyvaso (treprostinil) is a small molecule pharmaceutical. Treprostinil was first approved as Remodulin on 2002-05-21. It is used to treat pulmonary hypertension in the USA. It has been approved in Europe to treat pulmonary hypertension. The pharmaceutical is active against prostacyclin receptor. In addition, it is known to target prostaglandin E2 receptor EP3 subtype, prostaglandin E2 receptor EP1 subtype, prostaglandin E2 receptor EP2 subtype, prostaglandin D2 receptor, and prostaglandin E2 receptor EP4 subtype.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Remodulin, Treprostinil, Tyvaso, Tyvaso dpi (discontinued: Remodulin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Treprostinil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REMODULIN | United Therapeutics | N-021272 RX | 2002-05-21 | 8 products, RLD, RS |
| TYVASO DPI | United Therapeutics | N-214324 RX | 2022-05-23 | 5 products, RLD, RS |
| TYVASO | United Therapeutics | N-022387 RX | 2009-07-30 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diluent treprostinil | ANDA | 2023-04-06 |
| orenitram | New Drug Application | 2023-11-07 |
| remodulin | New Drug Application | 2014-12-31 |
| remodulin sterile diluent for remodulin | New Drug Application | 2023-10-09 |
| sterile diluent for treprostinil treprostinil | ANDA | 2021-12-23 |
| treprostinil | ANDA | 2023-01-25 |
| tyvaso | New Drug Application | 2024-09-11 |
| tyvaso dpi | New Drug Application | 2024-08-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary hypertension | EFO_0001361 | D006976 | I27.20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TREPROSTINIL DIOLAMINE, ORENITRAM, UNITED THERAP | |||
| 2026-10-18 | ODE-272 | ||
TREPROSTINIL, TYVASO, UNITED THERAP | |||
| 2024-03-31 | I-856 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Treprostinil, Tyvaso, United Therap | |||
| 11826327 | 2042-01-04 | U-3749 | |
| 9358240 | 2028-05-05 | U-1849 | |
| 9339507 | 2028-03-10 | DP | |
| 10376525 | 2027-05-14 | U-1849 | |
| 10716793 | 2027-05-14 | U-1849 | |
| Treprostinil, Tyvaso Dpi, United Therap | |||
| 10421729 | 2035-04-01 | DP | |
| 10772883 | 2030-06-11 | DP | |
| 10130685 | 2025-08-23 | DP | |
| Treprostinil Diolamine, Orenitram, United Therap | |||
| 8747897 | 2031-08-11 | DP | U-2724, U-2725 |
| 8349892 | 2031-01-22 | DP | |
| 8410169 | 2030-02-13 | DP | |
| 8497393 | 2028-12-15 | DP | |
| 7417070 | 2026-07-30 | DP | |
| 9393203 | 2026-04-27 | DP | U-1877 |
| 7544713 | 2024-07-14 | U-1475 | |
| 8252839 | 2024-05-24 | DP | |
| 9050311 | 2024-05-24 | DS, DP | |
| 9278901 | 2024-05-24 | U-1475 | |
| 9422223 | 2024-05-24 | DP | |
| Treprostinil, Remodulin, United Therap | |||
| 7999007 | 2029-03-29 | DP | U-1437 |
| 9593066 | 2028-12-15 | DP | |
| 9604901 | 2028-12-15 | DP | |
| 11723887 | 2028-12-15 | DP | |
| 8653137 | 2028-09-05 | U-1437 | |
| 8658694 | 2028-09-05 | U-1437 | |
| 9713599 | 2024-12-16 | U-2036 | |
| 10076505 | 2024-12-16 | DP | |
| 10695308 | 2024-12-16 | U-2845 | |
| 9199908 | 2024-05-24 | U-1771 | |
Clinical
Clinical Trials
139 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 5 | 22 | 30 | 19 | 20 | 92 |
| Pulmonary arterial hypertension | D000081029 | — | — | 10 | 11 | 20 | 18 | 15 | 73 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 3 | 14 | 19 | 7 | 9 | 49 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | 8 | 15 | 12 | 10 | 45 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 9 | 10 | 1 | 4 | 21 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 1 | 1 | — | 2 |
| Ventricular remodeling | D020257 | — | — | — | — | — | 1 | — | 1 |
| Lung transplantation | D016040 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | — | 7 | 7 | — | 3 | 14 |
| Pulmonary fibrosis | D011658 | — | — | — | 5 | 6 | — | 1 | 10 |
| Fibrosis | D005355 | — | — | — | 3 | 4 | — | — | 7 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 2 | 2 | — | 1 | 6 |
| Ischemia | D007511 | EFO_0000556 | — | 2 | 4 | 2 | — | — | 6 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | 2 | 2 | — | 1 | 5 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 2 | 3 | — | — | 5 |
| Chronic limb-threatening ischemia | D000089802 | — | — | — | 3 | 2 | — | — | 4 |
| Foot ulcer | D016523 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | 2 | 2 | — | 1 | 3 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | 1 | — | — | — | 7 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | 3 | 5 | — | — | — | 6 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 3 | 5 | — | — | — | 6 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 2 | 1 | — | — | — | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | — | — | 1 | 3 |
| Sclerosis | D012598 | — | — | 1 | 2 | — | — | — | 3 |
| Wounds and injuries | D014947 | — | T14.8 | 2 | 1 | — | — | — | 2 |
| Reperfusion injury | D015427 | — | — | 2 | 1 | — | — | — | 2 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | 1 | — | — | 1 | 2 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 1 | — | — | 1 | 2 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Univentricular heart | D000080039 | — | Q20.4 | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Dialysis | D003956 | — | — | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Treprostinil |
| INN | treprostinil |
| Description | Treprostinil is a carboxylic acid and a carbotricyclic compound. It has a role as a platelet aggregation inhibitor, a vasodilator agent, an antihypertensive agent, a cardiovascular drug, a vitamin K antagonist and a human blood serum metabolite. |
| Classification | Small molecule |
| Drug class | prostaglandins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC[C@H](O)CC[C@@H]1[C@H]2Cc3cccc(OCC(=O)O)c3C[C@H]2C[C@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 81846-19-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1237119 |
| ChEBI ID | 50861 |
| PubChem CID | 6918140 |
| DrugBank | DB00374 |
| UNII ID | RUM6K67ESG (ChemIDplus, GSRS) |
Target
Agency Approved
PTGIR
PTGIR
Organism
Homo sapiens
Gene name
PTGIR
Gene synonyms
PRIPR
NCBI Gene ID
Protein name
prostacyclin receptor
Protein synonyms
PGI receptor, PGI2 receptor, prostaglandin I2 (prostacyclin) receptor (IP), Prostaglandin I2 receptor, Prostanoid IP receptor
Uniprot ID
Mouse ortholog
Ptgir (19222)
prostacyclin receptor (Q52KE5)
Alternate
PTGER3
PTGER3
PTGER1
PTGER1
PTGER2
PTGER2
PTGDR
PTGDR
PTGER4
PTGER4
Organism
Homo sapiens
Gene name
PTGER3
Gene synonyms
NCBI Gene ID
Protein name
prostaglandin E2 receptor EP3 subtype
Protein synonyms
PGE receptor, EP3 subtype, PGE2 receptor EP3 subtype, PGE2-R, prostaglandin E receptor 3 (subtype EP3), prostaglandin receptor (PGE-2), Prostanoid EP3 receptor
Uniprot ID
Mouse ortholog
Ptger3 (19218)
prostaglandin E2 receptor EP3 subtype (P30557)
Variants
No data
Financial
Revenue by drug
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Orenitram – United Therapeutics
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Tyvaso – United Therapeutics
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Remodulin – United Therapeutics
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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84,692 adverse events reported
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