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Drug ReportsAlprostadil
Alprostadil
Alprostadil, Caverject, Edex, 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 prostaglandin E2 receptor EP3 subtype, cation channel sperm-associated protein 1, prostacyclin receptor, cation channel sperm-associated protein 2, cation channel sperm-associated protein 4, cation channel sperm-associated protein 3, prostaglandin E2 receptor EP4 subtype, and prostaglandin D2 receptor.
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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
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Alprostadil, Caverject, Edex, Prostin (discontinued: Caverject, Edex, Muse)
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
EDEXEndoN-020649 RX1997-06-12
6 products, RLD, RS
CAVERJECTPfizerN-020379 RX1995-07-06
3 products, RLD, RS
CAVERJECT IMPULSEPfizerN-021212 RX2002-06-11
2 products
PROSTIN VR PEDIATRICPfizerN-018484 RX1982-01-01
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
alprostadilANDA2024-06-04
caverjectNew Drug Application2024-05-13
caverject impulseNew Drug Application2024-07-23
edexNew Drug Application2024-03-27
may new york secret muse himiznohana cover pact no 21OTC monograph not final2018-06-04
may new york secret muse uv vita sun cushionOTC monograph not final2018-06-04
muse health hand sanitizerOTC monograph not final2022-04-26
muse health hand sanitizer - fragrance freeOTC monograph not final2022-04-27
musely daycream spf40C2002632024-12-26
prostinNew Drug Application2022-10-03
Show 2 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary hypertensionEFO_0001361D006976I27.20
tetralogy of fallotHP_0001636D013771Q21.3
patent ductus arteriosusHP_0001643D004374Q25.0
aortic coarctationEFO_1001267D001017Q25.1
vasculogenic impotenceEFO_1001234D018783—
tricuspid atresia—D018785—
pulmonary valve stenosisEFO_1001138D011666—
hypoplastic left heart syndrome—D018636Q23.4
aortic arch syndromes—D001015—
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
171 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Erectile dysfunctionD007172EFO_0004234F52.21——1—12
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Penile neoplasmsD010412—C60————11
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)Loading
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
RxCUI—
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
PTGER3
PTGER3
CATSPER1
CATSPER1
PTGIR
PTGIR
CATSPER2
CATSPER2
CATSPER4
CATSPER4
CATSPER3
CATSPER3
PTGER4
PTGER4
PTGDR
PTGDR
Organism
Homo sapiens
Gene name
PTGER3
Gene synonyms
NCBI Gene ID
5733
Protein name
prostaglandin E2 receptor EP3 subtype
Protein synonyms
PGE receptor, EP3 subtype, PGE2 receptor EP3 subtype, PGE2-R, prostaglandin E receptor 3 (subtype EP3), prostaglandin receptor (PGE-2), Prostanoid EP3 receptor
Uniprot ID
Q5CZ64
Mouse ortholog
Ptger3 (19218)
prostaglandin E2 receptor EP3 subtype (P30557)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Edex – Auxilium Pharmaceuticals
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Estimated US medical usage
Alprostadil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,797 documents
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Safety
Black-box Warning
Black-box warning for: Alprostadil, Prostin, Prostin vr pediatric
Adverse Events
Top Adverse Reactions
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91,567 adverse events reported
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