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
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alprostadil | ANDA | 2024-06-04 |
| caverject | New Drug Application | 2024-05-13 |
| caverject impulse | New Drug Application | 2024-02-29 |
| edex | New Drug Application | 2024-03-27 |
| hand sanitizer madrid muse | C200263 | 2026-03-19 |
| mhb skin hydrating hand sanitizer, melon muse | C200263 | 2026-01-14 |
| mhb skin hydrating hand sanitizer, melon muse 35ml | C200263 | 2026-04-30 |
| muse health hand sanitizer | OTC monograph not final | 2022-04-26 |
| muse health hand sanitizer - fragrance free | OTC monograph not final | 2022-04-27 |
| musely daycream spf40 | C200263 | 2024-12-26 |
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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
237 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | — | K59.0 | 3 | 3 | 16 | 7 | 6 | 32 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 4 | 2 | 1 | 6 | 13 |
| Induced labor | D007751 | — | — | — | 1 | 3 | 4 | 5 | 13 |
| Cervical ripening | D020070 | — | — | — | 1 | 2 | 1 | 3 | 7 |
| Premature rupture fetal membranes | D005322 | — | O42 | — | — | — | 4 | 2 | 6 |
| Ischemia | D007511 | EFO_0000556 | — | — | 2 | — | 1 | 1 | 4 |
| Obstetric labor complications | D007744 | — | — | — | 1 | 1 | 2 | 1 | 4 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | 1 | 1 | 1 | 1 | — | 4 |
| Postpartum hemorrhage | D006473 | — | O72 | — | 1 | — | 2 | 1 | 4 |
| Hysteroscopy | D015907 | — | — | — | — | — | 3 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 2 | 1 | 2 | — | 2 | 7 |
| Opioid-induced constipation | D000079689 | — | — | — | — | 4 | — | 2 | 6 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 2 | — | 1 | 5 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 2 | 1 | — | 2 | 5 |
| Syndrome | D013577 | — | — | — | 1 | 2 | — | 2 | 5 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | 1 | — | 2 | 4 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 2 | 1 | — | 1 | 4 |
| Gastrointestinal diseases | D005767 | — | — | — | — | 4 | — | — | 4 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | 4 | — | — | 4 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | — | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | 2 | 3 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 2 | — | — | 1 | 3 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | 1 | — | — | 1 | 2 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | 2 | 2 | — | — | — | 2 |
| Chronic chemical and drug induced liver injury | D056487 | EFO_1000905 | — | 2 | 2 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 2 | — | — | — | 2 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 2 | — | — | — | 2 |
| Physiological sexual dysfunction | D012735 | — | — | 1 | 1 | — | — | — | 2 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | 1 | 1 | — | — | — | 2 |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | 2 | — | — | — | 2 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | — | Q24.9 | 1 | — | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| Vasculogenic impotence | D018783 | EFO_1001234 | — | 1 | — | — | — | — | 1 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 1 | — | — | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
| Retained placenta | D018457 | — | O72.0 | 1 | — | — | — | — | 1 |
| Visceral pain | D059265 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 3 | 3 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | — | — | 3 | 3 |
| Psychological stress | D013315 | — | — | — | — | — | — | 2 | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 2 | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 2 | 2 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 2 | 2 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 2 | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 2 | 2 |
| Headache | D006261 | — | R51 | — | — | — | — | 2 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
Show 94 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
No data
Financial
Revenue by drug
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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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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 9,999 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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109,216 adverse events reported
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