Dinoprostone
Cervidil, Prepidil (dinoprostone) is a small molecule pharmaceutical. Dinoprostone was first approved as Prostin e2 on 1982-01-01. It is used to treat fetal death, gestational trophoblastic disease, and uterine neoplasms in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
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Cervidil, Prepidil (discontinued: Prostin e2)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dinoprostone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CERVIDIL | Ferring Pharmaceuticals | N-020411 RX | 1995-03-30 | 1 products, RLD, RS |
| PREPIDIL | Pfizer | N-019617 RX | 1992-12-09 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| uterine neoplasms | EFO_0003859 | D014594 | C55 |
| gestational trophoblastic disease | — | D031901 | O01.9 |
| fetal death | HP_0003826 | D005313 | — |
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Clinical
Clinical Trials
172 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 | — | — | — | 4 | 6 | 8 | 12 | 30 |
| Cervical ripening | D020070 | — | — | — | 1 | 8 | 5 | 5 | 19 |
| Premature rupture fetal membranes | D005322 | HP_0001788 | O42 | 1 | 2 | 1 | 6 | 3 | 12 |
| Rupture | D012421 | — | — | 1 | 2 | — | 6 | 3 | 11 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | 2 | 2 | 4 | 9 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | 3 | 2 | 5 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 2 | 1 | 2 | 5 |
| Cataract | D002386 | HP_0000518 | H26.9 | — | — | — | 3 | 2 | 5 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 1 | — | 1 | 2 | 4 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | 1 | 2 | 3 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leiomyoma | D007889 | HP_0000131 | D25 | — | — | 1 | — | 1 | 2 |
| Myofibroma | D047708 | — | — | — | — | 1 | — | 1 | 2 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 1 | — | — | 2 |
| Fetal growth retardation | D005317 | EFO_0000495 | — | 1 | — | 1 | — | — | 2 |
| Prolonged pregnancy | D011273 | — | O48.0 | — | — | 1 | — | 1 | 2 |
| Eclampsia | D004461 | HP_0100601 | O15 | — | — | 1 | — | — | 1 |
| Labor pain | D048949 | — | — | — | — | 1 | — | — | 1 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | 1 | — | — | 1 |
| Enzyme induction | D004790 | — | — | — | — | 1 | — | — | 1 |
| Oligohydramnios | D016104 | EFO_0007401 | O41.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 2 | — | — | 1 | 6 |
| Colorectal neoplasms | D015179 | — | — | 3 | 3 | — | — | — | 4 |
| Headache | D006261 | HP_0002315 | R51 | 1 | 1 | — | — | 2 | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 1 | — | — | — | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | 1 | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | 1 | 2 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | 1 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 2 | — | — | — | 2 |
| Facial pain | D005157 | — | R51.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
Show 25 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | 1 | — | — | — | — | 1 |
| Smoking | D012907 | EFO_0004318 | — | 1 | — | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Metabolic brain diseases | D001928 | — | G93.41 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 3 | 3 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 3 | 3 |
| Anesthesia | D000758 | — | — | — | — | — | — | 2 | 2 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | — | 2 | 2 |
| Peri-implantitis | D057873 | EFO_1001390 | — | — | — | — | — | 2 | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 2 | 2 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | — | — | 2 | 2 |
| Cough | D003371 | HP_0012735 | R05 | — | — | — | — | 2 | 2 |
| Chronic cough | D000096822 | — | R05.3 | — | — | — | — | 2 | 2 |
| Colonic neoplasms | D003110 | — | C18 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dinoprostone |
| INN | dinoprostone |
| Description | Prostaglandin E2 is prostaglandin F2alpha in which the hydroxy group at position 9 has been oxidised to the corresponding ketone. Prostaglandin E2 is the most common and most biologically potent of mammalian prostaglandins. It has a role as an oxytocic, a human metabolite and a mouse metabolite. It is a conjugate acid of a prostaglandin E2(1-). |
| Classification | Small molecule |
| Drug class | 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]1C/C=C\CCCC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 363-24-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL548 |
| ChEBI ID | 15551 |
| PubChem CID | 5280360 |
| DrugBank | DB00917 |
| UNII ID | K7Q1JQR04M (ChemIDplus, GSRS) |
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Safety
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Adverse Events
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1,220 adverse events reported
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