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Drug ReportsEpoprostenol
Epoprostenol
Epoprostenol, Flolan, Veletri (epoprostenol) is a small molecule pharmaceutical. Epoprostenol was first approved as Flolan on 1995-09-20. It is used to treat arteriosclerosis, peripheral vascular diseases, pulmonary hypertension, purpura, and respiratory distress syndrome amongst others in the USA. The pharmaceutical is active against prostaglandin E2 receptor EP1 subtype. In addition, it is known to target prostacyclin receptor and prostaglandin E2 receptor EP4 subtype.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Epoprostenol, Flolan, Veletri
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Epoprostenol sodium
Tradename
Company
Number
Date
Products
VELETRIActelionN-022260 RX2008-06-27
2 products, RLD, RS
FLOLANGSKN-020444 RX1995-09-20
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
diluent flolanNew Drug Application2023-10-26
epoprostenolANDA2024-10-03
flolanNew Drug Application2016-06-22
veletriNew Drug Application2022-11-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary hypertensionEFO_0001361D006976I27.20
respiratory distress syndromeEFO_1000637D012128J80
systemic sclerodermaEFO_0000717D012595M34.0
arteriosclerosisEFO_0009086D001161I70
peripheral vascular diseasesEFO_0003875D016491I73.9
purpuraHP_0000979D011693D69.2
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Epoprostenol Sodium, Veletri, Actelion
83188022027-03-15DP
85982272027-02-02
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AC: Platelet aggregation inhibitors excl. heparin
— B01AC09: Epoprostenol
HCPCS
Code
Description
J1325
Injection, epoprostenol, 0.5 mg
K0455
Infusion pump used for uninterrupted parenteral administration of medication, (e.g., epoprostenol or treprostinol)
S0155
Sterile dilutant for epoprostenol, 50 ml
S9347
Home infusion therapy, uninterrupted, long-term, controlled rate intravenous or subcutaneous infusion therapy (e.g., epoprostenol); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
Clinical
Clinical Trials
186 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 hypertensionD000081029——112228
HypertensionD006973EFO_0000537I10—12227
Familial primary pulmonary hypertensionD065627—I27.0—12216
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary hypertensionD006976EFO_0001361I27.20—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital heart defectsD006330HP_0001627Q24.9————11
Heart diseasesD006331EFO_0003777I51.9————11
Eisenmenger complexD004541—I27.83————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEpoprostenol
INNepoprostenol
Description
Prostaglandin I2 is a prostaglandins I. It has a role as a mouse metabolite. It is a conjugate acid of a prostaglandin I2(1-).
Classification
Small molecule
Drug classprostaglandins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)C[C@@H]2O/C(=C\CCCC(=O)O)C[C@@H]21
Identifiers
PDB—
CAS-ID35121-78-9
RxCUI—
ChEMBL IDCHEMBL1139
ChEBI ID15552
PubChem CID5282411
DrugBankDB01240
UNII IDDCR9Z582X0 (ChemIDplus, GSRS)
Target
Agency Approved
PTGER1
PTGER1
Organism
Homo sapiens
Gene name
PTGER1
Gene synonyms
NCBI Gene ID
5731
Protein name
prostaglandin E2 receptor EP1 subtype
Protein synonyms
PGE receptor, EP1 subtype, PGE2 receptor EP1 subtype, prostaglandin E receptor 1 (subtype EP1), 42kD, prostaglandin E receptor 1 (subtype EP1), 42kDa, prostaglandin E receptor 1, subtype EP1, Prostanoid EP1 receptor
Uniprot ID
Q8NHB2
Mouse ortholog
Ptger1 (19216)
prostaglandin E2 receptor EP1 subtype (P35375)
Alternate
PTGIR
PTGIR
PTGER4
PTGER4
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)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 40,066 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,267 adverse events reported
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