Hydroxyprogesterone caproate
Delalutin (hydroxyprogesterone caproate) is a small molecule pharmaceutical. Hydroxyprogesterone caproate was first approved as Hydroxyprogesterone caproate on 1982-01-01.
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Hydroxyprogesterone caproate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYDROXYPROGESTERONE CAPROATE | Allergan | N-017439 DISCN | 1982-01-01 | 2 products |
| DELALUTIN | Bristol Myers Squibb | N-010347 DISCN | 1982-01-01 | 2 products, RLD |
| DELALUTIN | Bristol Myers Squibb | N-016911 DISCN | 1982-01-01 | 2 products, RLD |
| HYDROXYPROGESTERONE CAPROATE | Epic Pharma | N-018004 DISCN | 1982-01-01 | 1 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| advanced formula progesto-life | unapproved drug other | 2022-03-31 |
| bijuva | New Drug Application | 2023-12-07 |
| crinone | New Drug Application | 2024-05-21 |
| endometrin | New Drug Application | 2022-08-16 |
| estradiol and progesterone | ANDA | 2024-06-07 |
| fluocinolone acetonide 0.01% / minoxidil 7% / progesterone 0.1% | unapproved drug other | 2019-05-08 |
| hemacord | Biologic Licensing Application | 2022-10-19 |
| hydroxyprogesterone caproate | ANDA | 2022-06-22 |
| minoxidil 5% / progesterone 0.1% / tretinoin 0.025% | unapproved drug other | 2019-05-06 |
| minoxidil 7% / progesterone 0.1% | unapproved drug other | 2019-04-24 |
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Clinical Trials
58 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 5 | 11 | 3 | 9 | 26 |
| Infertility | D007246 | HP_0000789 | — | — | — | 1 | 1 | 2 | 4 |
| Premature obstetric labor | D007752 | — | O60 | — | 1 | 1 | 1 | 1 | 4 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | 1 | — | 1 | 1 | 3 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | 1 | 1 | 2 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 1 | 2 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | — | 1 | — | 1 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 2 | 2 | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 2 | — | — | 3 |
| Rupture | D012421 | — | — | 1 | 3 | 1 | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | 1 | — | — | 1 |
| Fertility preservation | D059247 | — | — | — | 1 | 1 | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | — | 1 |
| Cervical length measurement | D054791 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperplasia | D006965 | EFO_0000536 | — | 1 | 2 | — | — | — | 3 |
| Congenital adrenal hyperplasia | D000312 | — | E25.0 | 1 | 2 | — | — | — | 3 |
| Adrenogenital syndrome | D047808 | — | E25.9 | 1 | 2 | — | — | — | 3 |
| Adrenocortical hyperfunction | D000308 | EFO_1000797 | — | 1 | 2 | — | — | — | 3 |
| Placenta previa | D010923 | EFO_0007442 | O44 | — | 1 | — | — | 2 | 3 |
| Bulimia | D002032 | — | F50.2 | — | 1 | — | — | — | 1 |
| Bulimia nervosa | D052018 | EFO_0005204 | F50.2 | — | 1 | — | — | — | 1 |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | 1 | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disorders of sex development | D012734 | HP_0000062 | Q56.3 | 1 | — | — | — | 1 | 2 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | 1 | — | — | — | — | 1 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | 1 | — | — | — | — | 1 |
| Urogenital abnormalities | D014564 | — | — | 1 | — | — | — | — | 1 |
| Adrenal gland diseases | D000307 | HP_0000834 | E27.9 | 1 | — | — | — | — | 1 |
| Inborn errors steroid metabolism | D043202 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 1 | 1 |
| Dental caries | D003731 | EFO_0003819 | K02 | — | — | — | — | 1 | 1 |
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
| Fertilization in vitro | D005307 | — | — | — | — | — | — | 1 | 1 |
| Luteal phase | D008183 | — | — | — | — | — | — | 1 | 1 |
| Uterine hemorrhage | D014592 | — | — | — | — | — | — | 1 | 1 |
| Fetal growth retardation | D005317 | EFO_0000495 | — | — | — | — | — | 1 | 1 |
| Abruptio placentae | D000037 | EFO_1001754 | O45 | — | — | — | — | 1 | 1 |
| Eclampsia | D004461 | HP_0100601 | O15 | — | — | — | — | 1 | 1 |
| Threatened abortion | D000033 | — | O20.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hydroxyprogesterone caproate |
| INN | hydroxyprogesterone caproate |
| Description | Hydroxyprogesterone caproate is a corticosteroid hormone. |
| Classification | Small molecule |
| Drug class | progestins; steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 630-56-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200848 |
| ChEBI ID | 5812 |
| PubChem CID | 169870 |
| DrugBank | DB06789 |
| UNII ID | 276F2O42F5 (ChemIDplus, GSRS) |
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Additional graphs summarizing 7,171 documents
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Safety
Black-box Warning
Black-box warning for: Bijuva, Estradiol and progesterone, Hemacord, Prometrium
Adverse Events
Top Adverse Reactions
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48,748 adverse events reported
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