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Alprostadil
Caverject, Edex, Muse, Prostin (alprostadil) is a small molecule pharmaceutical. Alprostadil was first approved as Prostin vr pediatric on 1982-01-01. It is used to treat aortic arch syndromes, aortic coarctation, hypoplastic left heart syndrome, patent ductus arteriosus, and pulmonary hypertension amongst others in the USA. The pharmaceutical is active against prostaglandin E2 receptor EP1 subtype and prostaglandin E2 receptor EP2 subtype. In addition, it is known to target cation channel sperm-associated protein 3, prostacyclin receptor, prostaglandin D2 receptor, cation channel sperm-associated protein 4, cation channel sperm-associated protein 2, cation channel sperm-associated protein 1, prostaglandin E2 receptor EP4 subtype, and prostaglandin E2 receptor EP3 subtype.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Caverject, Edex, Muse, Prostin (generic drugs available since 1998-01-20)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alprostadil
Tradename
Company
Number
Date
Products
EDEXAuxilium PharmaceuticalsN-020649 RX1997-06-12
6 products, RLD, RS
MUSEMylanN-020700 RX1996-11-19
3 products, RLD, RS
PROSTIN VR PEDIATRICMylanN-018484 RX1982-01-01
1 products, RLD, RS
CAVERJECTMylanN-020379 RX1995-07-06
3 products, RLD, RS
CAVERJECT IMPULSEMylanN-021212 RX2002-06-11
2 products
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
alprostadilANDA2020-02-29
caverjectNew Drug Application2023-03-24
edexNew Drug Application2018-08-22
prostin New Drug Application2022-10-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aortic arch syndromes—D001015—
aortic coarctationEFO_1001267D001017Q25.1
hypoplastic left heart syndrome—D018636Q23.4
patent ductus arteriosusHP_0001643D004374Q25.0
pulmonary hypertensionEFO_0001361D006976I27.20
pulmonary valve stenosisEFO_1001138D011666—
tetralogy of fallotHP_0001636D013771Q21.3
tricuspid atresia—D018785—
vasculogenic impotenceEFO_1001234D018783—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01E: Other cardiac preparations in atc
— C01EA: Prostaglandin cardiac therapy preparations
— C01EA01: Alprostadil
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04B: Urologicals
— G04BE: Drugs used in erectile dysfunction
— G04BE01: Alprostadil
HCPCS
Code
Description
J0270
Injection, alprostadil, 1.25 mcg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
J0275
Alprostadil urethral suppository (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L20———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EczemaD004485HP_0000964L30.9——4——4
Hand dermatosesD006229——3——3
Male breast neoplasmsD018567——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD04855011——12
Hiv infectionsD015658EFO_0000764B20—1——12
Kaposi sarcomaD012514C46—1——12
Lichen planusD008010L43—1———1
Cutaneous lupus erythematosusD008178EFO_0003834L93.1—1———1
PsoriasisD011565EFO_0000676L40—1———1
TuberculosisD014376EFO_0000774A15-A19—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameALPROSTADIL
INNalprostadil
Description
Prostaglandin E1 is a prostaglandins E. It has a role as a platelet aggregation inhibitor, a vasodilator agent, an anticoagulant and a human metabolite. It is a conjugate acid of a prostaglandin E1(1-).
Classification
Small molecule
Drug classvasodilators (undefined group); prostaglandins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)O
Identifiers
PDB—
CAS-ID745-65-3
RxCUI598
ChEMBL IDCHEMBL495
ChEBI ID15544
PubChem CID5280723
DrugBankDB00770
UNII IDF5TD010360 (ChemIDplus, GSRS)
Target
Agency Approved
PTGER1
PTGER1
PTGER2
PTGER2
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
CATSPER3
CATSPER3
PTGIR
PTGIR
PTGDR
PTGDR
CATSPER4
CATSPER4
CATSPER2
CATSPER2
CATSPER1
CATSPER1
PTGER4
PTGER4
PTGER3
PTGER3
Organism
Homo sapiens
Gene name
CATSPER3
Gene synonyms
NCBI Gene ID
347732
Protein name
cation channel sperm-associated protein 3
Protein synonyms
Ca(v)-like protein, calcium channel repeat containing 1, One-repeat calcium channel-like protein, putative ion channel CatSper3
Uniprot ID
Q86XS6
Mouse ortholog
Catsper3 (76856)
cation channel sperm-associated protein 3 (Q9D5T9)
Variants
Clinical Variant
No data
Financial
Edex - Auxilium Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,338 documents
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Safety
Black-box Warning
Black-box warning for: Alprostadil, Prostin
Adverse Events
Top Adverse Reactions
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63 adverse events reported
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