Treprostinil palmitil
Orenitram, Remodulin, Treprostinil, Trepulmix, Tyvaso (treprostinil palmitil) is a small molecule pharmaceutical. Treprostinil palmitil was first approved as Remodulin on 2002-05-21. It has been approved in Europe to treat pulmonary hypertension.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
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
No data
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 | |
ATC Codes
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HCPCS
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Clinical
Clinical Trials
137 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 |
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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 11 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 palmitil |
| INN | treprostinil palmitil |
| Description | Orenitram, Remodulin, Trepulmix, Tyvaso (treprostinil palmitil) is a small molecule pharmaceutical. Treprostinil palmitil was first approved as Remodulin on 2002-05-21. It has been approved in Europe to treat pulmonary hypertension. |
| Classification | Small molecule |
| Drug class | prostaglandins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCCCCCCCCCOC(=O)COc1cccc2c1C[C@H]1C[C@@H](O)[C@H](CC[C@@H](O)CCCCC)[C@H]1C2 |
Identifiers
| PDB | — |
| CAS-ID | 1706528-83-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650232 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 8GJK87S89F (ChemIDplus, GSRS) |
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Remodulin – United Therapeutics
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Tyvaso – United Therapeutics
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Orenitram – United Therapeutics
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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84,693 adverse events reported
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