Alprostadil
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 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
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 |
|---|---|---|---|---|
| EDEX | Auxilium Pharmaceuticals | N-020649 RX | 1997-06-12 | 6 products, RLD, RS |
| MUSE | Mylan | N-020700 RX | 1996-11-19 | 3 products, RLD, RS |
| PROSTIN VR PEDIATRIC | Mylan | N-018484 RX | 1982-01-01 | 1 products, RLD, RS |
| CAVERJECT | Mylan | N-020379 RX | 1995-07-06 | 3 products, RLD, RS |
| CAVERJECT IMPULSE | Mylan | N-021212 RX | 2002-06-11 | 2 products |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| caverject | New Drug Application | 2023-03-24 |
| caverject impulse | New Drug Application | 2023-01-27 |
| edex | New Drug Application | 2022-07-11 |
| muse | New Drug Application | 2018-04-25 |
| muse health hand sanitizer | OTC monograph not final | 2022-04-26 |
| muse health hand sanitizer - fragrance free | OTC monograph not final | 2022-04-27 |
| prostin | New Drug Application | 2022-10-03 |
| prostin vr pediatric | 2006-04-20 | |
| secret muse vita blue sun | OTC monograph not final | 2018-06-04 |
Indications
FDA
EMA
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
166 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induced labor | D007751 | — | — | — | 1 | 3 | 3 | 4 | 11 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 2 | 1 | 1 | 5 | 9 |
| Cervical ripening | D020070 | — | — | — | 1 | 2 | 1 | 1 | 5 |
| Liver failure | D017093 | HP_0001399 | K72.9 | — | 1 | — | 1 | 1 | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | 1 | 2 | 3 |
| Obstetric labor complications | D007744 | — | — | — | 1 | 1 | 1 | 1 | 3 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | 1 | — | 1 | 1 | — | 3 |
| Postpartum hemorrhage | D006473 | — | O72 | — | — | — | 2 | 1 | 3 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | 1 | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | — | 1 | — | 2 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | 1 | — | 2 | 4 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | 1 | — | — | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 1 | — | 1 | 2 |
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | 1 | — | — | 1 |
| Transient tachypnea of the newborn | D059245 | — | P22.1 | — | — | 1 | — | — | 1 |
| Maternal obesity | D000079262 | — | — | — | — | 1 | — | — | 1 |
| Hepatic veno-occlusive disease | D006504 | — | K76.5 | — | 1 | 1 | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | — | 1 |
| Labor pain | D048949 | — | — | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 2 | — | — | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | 1 | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | 1 | 2 |
| Chronic chemical and drug induced liver injury | D056487 | EFO_1000905 | — | 2 | 2 | — | — | — | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 2 | — | — | — | 2 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 2 | — | — | — | 2 |
| Actinic keratosis | D055623 | — | L57.0 | — | 2 | — | — | — | 2 |
| Extracorporeal membrane oxygenation | D015199 | — | — | — | 1 | — | — | — | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 1 | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | 1 | — | — | — | 1 | 2 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 1 | — | — | — | — | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | — | — | — | 1 |
| Retained placenta | D018457 | — | O72.0 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 2 | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 2 | 2 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 2 | 2 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 2 | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Platelet aggregation | D010974 | GO_0070527 | — | — | — | — | — | 1 | 1 |
| Penile neoplasms | D010412 | — | C60 | — | — | — | — | 1 | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | — | — | 1 | 1 |
| Rosacea | D012393 | — | L71 | — | — | — | — | 1 | 1 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | — | 1 | 1 |
Show 34 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alprostadil |
| INN | alprostadil |
| 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 class | vasodilators (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-ID | 745-65-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL495 |
| ChEBI ID | 15544 |
| PubChem CID | 5280723 |
| DrugBank | DB00770 |
| UNII ID | F5TD010360 (ChemIDplus, GSRS) |
Target
Agency Approved
PTGER1
PTGER1
PTGER2
PTGER2
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
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
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
Mouse ortholog
Ptger3 (19218)
prostaglandin E2 receptor EP3 subtype (P30557)
Variants
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Financial
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,387 documents
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Safety
Black-box Warning
Black-box warning for: Prostin, Prostin vr pediatric
Adverse Events
Top Adverse Reactions
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62,520 adverse events reported
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