Misoprostol
Arthrotec, Cytotec, Misoprostol (misoprostol) is a small molecule pharmaceutical. Misoprostol was first approved as Cytotec on 1988-12-27. The pharmaceutical is active against prostaglandin E2 receptor EP3 subtype. In addition, it is known to target prostaglandin E2 receptor EP2 subtype and prostaglandin E2 receptor EP4 subtype.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Cytotec, Misoprostol
CombinationsArthrotec, Diclofenac misoprostol (discontinued: Diclofenac misoprostol)
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 |
|---|---|---|
| arthrotec | New Drug Application | 2023-08-16 |
| cytotec | New Drug Application | 2021-07-09 |
| dicloenac sodium and misoprostol | ANDA | 2024-02-23 |
| diclofenac sodium and misoprostol | NDA authorized generic | 2024-06-03 |
| diclofenac sodium misoprostol | ANDA | 2024-09-18 |
| diclofenac sodium/misoprostol | ANDA | 2024-04-09 |
| misoprostol | ANDA | 2024-10-24 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BB: Prostaglandin drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BB01: Misoprostol
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02A: Uterotonics
— G02AD: Prostaglandins, oxytocics
— G02AD06: Misoprostol
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE56: Naproxen and misoprostol
HCPCS
Code | Description |
|---|---|
| S0191 | Misoprostol, oral, 200 mcg |
Clinical
Clinical Trials
532 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | 4 | 13 | 27 | 24 | 38 | 100 |
| Postpartum hemorrhage | D006473 | — | O72 | 4 | 11 | 13 | 13 | 31 | 68 |
| Induced labor | D007751 | — | — | 4 | 10 | 8 | 11 | 25 | 57 |
| Induced abortion | D000028 | — | — | — | 1 | 6 | 13 | 24 | 44 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | 9 | 9 | 7 | 18 | 38 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 4 | 6 | 9 | 12 | 31 |
| Missed abortion | D000030 | — | O02.1 | 2 | 7 | 4 | 10 | 8 | 30 |
| Incomplete abortion | D000027 | EFO_1001799 | — | 1 | 2 | 3 | 4 | 15 | 25 |
| Cervical ripening | D020070 | — | — | — | 6 | 8 | 6 | 3 | 23 |
| Obstetric labor complications | D007744 | — | — | — | — | 1 | 2 | 10 | 13 |
Show 39 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 2 | — | 3 | 6 |
| Eclampsia | D004461 | HP_0100601 | O15 | — | — | 2 | — | 2 | 4 |
| Infertility | D007246 | HP_0000789 | — | — | 2 | 2 | — | 1 | 4 |
| Postoperative hemorrhage | D019106 | — | — | — | 1 | 1 | — | 3 | 4 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 2 | — | — | 2 |
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | 1 | — | 1 | 2 |
| Amenorrhea | D000568 | — | N91.2 | — | — | 1 | — | 1 | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | 1 | 2 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | — | 1 | — | 1 | 2 |
| Transient tachypnea of the newborn | D059245 | — | P22.1 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retained placenta | D018457 | — | O72.0 | 1 | 1 | — | — | 1 | 3 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | — | 1 | — | — | — | 1 |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | — | 1 | — | — | — | 1 |
| First pregnancy trimester | D011261 | — | — | — | 1 | — | — | — | 1 |
| Stem cell transplantation | D033581 | — | — | — | 1 | — | — | — | 1 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | 1 | — | — | — | 1 |
| Hemorrhagic cystitis | D000096722 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | — | — | — | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | 1 | — | — | — | — | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic constriction | D003251 | — | — | — | — | — | — | 3 | 3 |
| Emergencies | D004630 | — | — | — | — | — | — | 2 | 2 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | — | — | — | — | 2 | 2 |
| Prolonged pregnancy | D011273 | — | O48.0 | — | — | — | — | 2 | 2 |
| Obstetric delivery | D036861 | — | — | — | — | — | — | 2 | 2 |
| Intrauterine devices | D007434 | — | — | — | — | — | — | 2 | 2 |
| Cicatrix | D002921 | HP_0100699 | L90.5 | — | — | — | — | 2 | 2 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Misoprostol |
| INN | misoprostol |
| Description | 7-[(1R,2R,3R)-3-hydroxy-2-(4-hydroxy-4-methyloct-1-enyl)-5-oxocyclopentyl]heptanoic acid methyl ester is a prostanoid. |
| Classification | Small molecule |
| Drug class | prostaglandins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC |
Identifiers
| PDB | — |
| CAS-ID | 59122-46-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL606 |
| ChEBI ID | — |
| PubChem CID | 5282381 |
| DrugBank | DB00929 |
| UNII ID | 0E43V0BB57 (ChemIDplus, GSRS) |
Target
Agency Approved
PTGER3
PTGER3
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)
Alternate
PTGER2
PTGER2
PTGER4
PTGER4
Organism
Homo sapiens
Gene name
PTGER2
Gene synonyms
NCBI Gene ID
Protein name
prostaglandin E2 receptor EP2 subtype
Protein synonyms
PGE receptor EP2 subtype, PGE2 receptor EP2 subtype, prostaglandin E receptor 2 (subtype EP2), 53kD, prostaglandin E receptor 2 (subtype EP2), 53kDa, Prostanoid EP2 receptor
Uniprot ID
Mouse ortholog
Ptger2 (19217)
prostaglandin E2 receptor EP2 subtype (Q62053)
Variants
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Financial
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Arthrotec – Pfizer
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Estimated US medical usage
Misoprostol
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Diclofenac
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Misoprostol
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,800 documents
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Safety
Black-box Warning
Black-box warning for: Arthrotec, Cytotec, Dicloenac sodium and misoprostol, Diclofenac sodium and misoprostol, Diclofenac sodium misoprostol, Diclofenac sodium/misoprostol, Misoprostol
Adverse Events
Top Adverse Reactions
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10,002 adverse events reported
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