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
Trade Name
FDA
EMA
Flolan, Veletri (generic drugs available since 2008-04-23)
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diluent flolan | New Drug Application | 2023-10-26 |
| epoprostenol | ANDA | 2021-01-16 |
| flolan | New Drug Application | 2016-06-22 |
| veletri | New Drug Application | 2022-11-28 |
Agency Specific
FDA
EMA
No data
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
108 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 hypertension | D000081029 | — | — | 2 | 9 | 7 | 8 | 9 | 35 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | 4 | 5 | 8 | 4 | 22 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 3 | 1 | 1 | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 2 | 1 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 2 | 1 | — | 3 |
| Platelet aggregation | D010974 | GO_0070527 | — | — | — | — | 1 | — | 1 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | — | — | — | 1 | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | 1 | — | 1 |
| Vitiligo | D014820 | EFO_0004208 | L80 | — | — | — | 1 | — | 1 |
| Excimer lasers | D054018 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | — | 5 | — | 2 | 7 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 3 | — | — | 3 |
| Respiratory tract diseases | D012140 | — | — | — | — | 3 | — | — | 3 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | 3 | — | — | 3 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 3 | — | — | 3 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 3 | — | — | 3 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | 1 | 1 | — | — | 1 |
| Septic shock | D012772 | — | A48.3 | — | 1 | 1 | — | — | 1 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | — | — | 1 | — | — | 1 |
| Cerebral small vessel diseases | D059345 | — | — | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Reperfusion injury | D015427 | — | — | 2 | 2 | — | — | — | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | 1 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | — | — | — | 2 |
| Schistosomiasis | D012552 | EFO_1001475 | B65 | — | 1 | — | — | — | 1 |
| Delayed graft function | D051799 | — | — | 1 | 1 | — | — | — | 1 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | 1 | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | — | — | — | 1 |
| Multiple organ failure | D009102 | EFO_1001373 | — | — | 1 | — | — | — | 1 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | — | — | — | 1 | 2 |
| Headache | D006261 | HP_0002315 | R51 | 1 | — | — | — | 1 | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | — | — | 2 | 2 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | — | — | 2 | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 2 | 2 |
| Eisenmenger complex | D004541 | — | I27.83 | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
| Chronic cough | D000096822 | — | R05.3 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | — | — | — | 1 | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Vasodilation | D014664 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Epoprostenol |
| INN | epoprostenol |
| 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 class | prostaglandins |
| Image (chem structure or protein) |  |
| 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-ID | 35121-78-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1139 |
| ChEBI ID | 15552 |
| PubChem CID | 5282411 |
| DrugBank | DB01240 |
| UNII ID | DCR9Z582X0 (ChemIDplus, GSRS) |
Target
Agency Approved
PTGER1
PTGER1
Organism
Homo sapiens
Gene name
PTGER1
Gene synonyms
NCBI Gene ID
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
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
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)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,039 adverse events reported
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