Last reviewed · How we verify
Delalutin (HYDROXYPROGESTERONE CAPROATE)
Delalutin (HYDROXYPROGESTERONE CAPROATE) is a progestin medication originally developed by ACTAVIS LABS UT INC and currently owned by Bristol Myers Squibb. It targets corticosteroid-binding globulin and is used to prevent premature labor. Delalutin is a small molecule drug that has been FDA-approved since 1975 and is available as a generic medication. It is off-patent and has multiple generic manufacturers. Key safety considerations include the potential for adverse effects on the fetus and mother during pregnancy.
At a glance
| Generic name | HYDROXYPROGESTERONE CAPROATE |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Progestin |
| Target | Corticosteroid-binding globulin |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1975 |
Approved indications
- Prevention of Premature Labor
Common side effects
- coughing
- dyspnea
- constriction of the chest
- allergic-like reactions
Drug interactions
- CYP2A6 Substrates
Key clinical trials
- Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth (PHASE4)
- Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage (NA)
- Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia (PHASE2)
- Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth (PHASE1,PHASE2)
- Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer (PHASE2)
- 17-OHPC in Pregnancy: IM vs SC Routes
- Androgen Reduction in Congenital Adrenal Hyperplasia (PHASE2)
- Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |