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Remodulin, Trepulmix(treprostinil)
Orenitram, Remodulin, 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 D2 receptor, prostaglandin E2 receptor EP4 subtype, prostaglandin E2 receptor EP3 subtype, prostaglandin E2 receptor EP2 subtype, and prostaglandin E2 receptor EP1 subtype.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Orenitram, Remodulin, Tyvaso, Tyvaso dpi (generic drugs available since 2017-11-30)
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
REMODULINUnited TherapeuticsN-021272 RX2002-05-21
5 products, RLD, RS
TYVASOUnited TherapeuticsN-022387 RX2009-07-30
1 products, RLD, RS
TYVASO DPIUnited TherapeuticsN-214324 RX2022-05-23
4 products, RLD, RS
Show 1 discontinued
Treprostinil diolamine
Tradename
Company
Number
Date
Products
ORENITRAMUnited TherapeuticsN-203496 RX2013-12-20
5 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
diluent treprostinilANDA2023-04-06
orenitramNew Drug Application2021-07-13
remodulin sterile diluent for remodulinNew Drug Application2021-02-24
tyvasoNew Drug Application2022-09-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary hypertensionEFO_0001361D006976I27.20
Agency Specific
FDA
EMA
Expiration
Code
TREPROSTINIL DIOLAMINE, ORENITRAM, UNITED THERAP
2026-10-18ODE-272
TREPROSTINIL, TYVASO, UNITED THERAP
2024-03-31I-856
Patent Expiration
Patent
Expires
Flag
FDA Information
Treprostinil, Tyvaso Dpi, United Therap
104217292035-04-01DP
107728832030-06-11DP
101306852025-08-23DP
Treprostinil Diolamine, Orenitram, United Therap
87478972031-08-11DPU-2724, U-2725
83498922031-01-22DP
84101692030-02-13DP
84973932028-12-15DP
74170702026-07-30DP
93932032026-04-27DPU-1877
75447132024-07-14U-1475
82528392024-05-24DP
90503112024-05-24DS, DP
92789012024-05-24U-1475
94222232024-05-24DP
Treprostinil, Remodulin, United Therap
79990072029-03-29DPU-1437
95930662028-12-15DP
96049012028-12-15DP
86531372028-09-05U-1437
86586942028-09-05U-1437
97135992024-12-16U-2036
100765052024-12-16DP
106953082024-12-16U-2845
91999082024-05-24U-1771
Treprostinil, Tyvaso, United Therap
93582402028-05-05U-1849
93395072028-03-10DP
103765252027-05-14U-1849
107167932027-05-14U-1849
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AC: Platelet aggregation inhibitors excl. heparin
— B01AC21: Treprostinil
HCPCS
Code
Description
J3285
Injection, treprostinil, 1 mg
J7686
Treprostinil, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, 1.74 mg
Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary arterial hypertensionD0000810291091012646
Pulmonary hypertensionD006976EFO_0001361I27.20310156233
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Interstitial lung diseasesD017563EFO_0004244J84.89—66—110
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9122——5
Idiopathic pulmonary fibrosisD054990J84.112—23——5
Pulmonary fibrosisD011658J84.10—32—14
IschemiaD007511EFO_0000556—21——3
Familial primary pulmonary hypertensionD065627I27.0——2——2
Peripheral vascular diseasesD016491EFO_0003875I73.9—12——2
Heart failureD006333EFO_0003144I50——1——1
Liver transplantationD016031EFO_0010682—11——1
Foot ulcerD016523——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Systemic sclerodermaD012595EFO_0000717M3435———6
Healthy volunteers/patients—51———5
Reperfusion injuryD01542722———2
Congenital heart defectsD006330HP_0001627Q24.9—1——12
Delayed graft functionD05179911———1
SarcoidosisD012507EFO_0000690D80-D89—1———1
Diabetic footD017719EFO_100145911———1
CalcinosisD002114—1———1
Respiratory distress syndromeD012128EFO_1000637J80—1———1
Persistent fetal circulation syndromeD010547EFO_1001103P29.3—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Raynaud diseaseD011928EFO_1001145I73.01————1
Type 1 diabetes mellitusD003922EFO_0001359E101————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTREPROSTINIL
INNtreprostinil
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 classprostaglandins
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-ID81846-19-7
RxCUI343048
ChEMBL IDCHEMBL1237119
ChEBI ID50861
PubChem CID6918140
DrugBankDB00374
UNII IDRUM6K67ESG (ChemIDplus, GSRS)
Target
Agency Approved
PTGIR
PTGIR
Organism
Homo sapiens
Gene name
PTGIR
Gene synonyms
PRIPR
NCBI Gene ID
5739
Protein name
prostacyclin receptor
Protein synonyms
PGI receptor, PGI2 receptor, prostaglandin I2 (prostacyclin) receptor (IP), Prostaglandin I2 receptor, Prostanoid IP receptor
Uniprot ID
P43119
Mouse ortholog
Ptgir (19222)
prostacyclin receptor (Q52KE5)
Alternate
PTGDR
PTGDR
PTGER4
PTGER4
PTGER3
PTGER3
PTGER2
PTGER2
PTGER1
PTGER1
Organism
Homo sapiens
Gene name
PTGDR
Gene synonyms
NCBI Gene ID
5729
Protein name
prostaglandin D2 receptor
Protein synonyms
PGD2 receptor, Prostanoid DP receptor
Uniprot ID
Q1ZZ52
Mouse ortholog
Ptgdr (19214)
prostaglandin D2 receptor (Q8CCM3)
Variants
Clinical Variant
No data
Financial
Remodulin - United Therapeutics
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Orenitram - United Therapeutics
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Tyvaso - United Therapeutics
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,091 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,131 adverse events reported
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