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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Commercial
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Trade Name
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Allocord, Clevecord, Cordcyte, Ducord, N/a (discontinued: Delalutin, Hydroxyprogesterone caproate)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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 | 2025-01-28 |
| 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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Indications
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Clinical
Clinical Trials
161 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 7 | 23 | 9 | 1 | 4 | 38 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 7 | 17 | 9 | 1 | 4 | 33 |
| Lymphoid leukemia | D007945 | — | C91 | 5 | 16 | 8 | 1 | 4 | 30 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 5 | 11 | 3 | 8 | 25 |
| Lymphoma | D008223 | — | C85.9 | 5 | 15 | 2 | 1 | — | 19 |
| Syndrome | D013577 | — | — | 1 | 1 | 1 | 1 | 2 | 6 |
| Infertility | D007246 | EFO_0000545 | — | — | — | 1 | 1 | 3 | 5 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 3 | 2 | — | 1 | — | 4 |
| Premature obstetric labor | D007752 | — | O60 | — | 1 | 1 | 1 | 1 | 4 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | 1 | — | 7 | 8 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | 1 | 1 | 1 | — | 5 | 7 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | 2 | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 2 | — | — | 3 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | 1 | 1 | — | — | 3 |
| Rupture | D012421 | — | — | 1 | 3 | 1 | — | — | 3 |
| Sclerosis | D012598 | — | — | 1 | 1 | 1 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | 1 | — | — | 2 |
| Contact dermatitis | D003877 | — | L25 | — | 1 | 1 | — | — | 2 |
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 7 | — | — | — | 7 |
| Hematologic neoplasms | D019337 | — | — | 1 | 6 | — | — | 1 | 7 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 6 | — | — | 1 | 7 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 6 | — | — | 1 | 7 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 6 | — | — | — | 6 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 6 | — | — | — | 6 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | 6 | — | — | — | 6 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 6 | — | — | — | 6 |
| Neoplasms | D009369 | — | C80 | 2 | 3 | — | — | 2 | 6 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | 1 | — | — | 5 | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inborn genetic diseases | D030342 | EFO_0000508 | — | 1 | — | — | — | 1 | 2 |
| Disorders of sex development | D012734 | — | Q56.3 | 1 | — | — | — | 1 | 2 |
| Hepatitis c | D006526 | — | B19.2 | 2 | — | — | — | — | 2 |
| Hepatitis | D006505 | — | K75.9 | 2 | — | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | — | — | — | 1 | 2 |
| Churg-strauss syndrome | D015267 | EFO_0007208 | M30.1 | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
Show 23 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aneurysm | D000783 | — | I72.9 | — | — | — | — | 6 | 6 |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | — | — | — | — | 6 | 6 |
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 3 | 3 |
| Pancreatic ductal carcinoma | D021441 | — | — | — | — | — | — | 3 | 3 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 2 | 2 |
| Pancreatic cyst | D010181 | — | K86.2 | — | — | — | — | 2 | 2 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 1 | 1 |
| Dental caries | D003731 | EFO_0003819 | K02 | — | — | — | — | 1 | 1 |
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
Show 38 more
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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Trends
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Safety
Black-box Warning
Black-box warning for: Bijuva, Estradiol and progesterone, Hemacord, Progesterone, Prometrium
Adverse Events
Top Adverse Reactions
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23,102 adverse events reported
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