{"id":"hydroxyprogesterone-caproate","rwe":[],"_fda":{"id":"b8f27635-ad16-41d2-a667-eaf51437947a","set_id":"687bcf42-f437-42c7-8909-a91f621f55df","openfda":{"unii":["276F2O42F5"],"route":["INTRAMUSCULAR"],"rxcui":["1087964"],"spl_id":["b8f27635-ad16-41d2-a667-eaf51437947a"],"brand_name":["Hydroxyprogesterone Caproate"],"spl_set_id":["687bcf42-f437-42c7-8909-a91f621f55df"],"package_ndc":["55150-311-01","55150-311-05"],"product_ndc":["55150-311"],"generic_name":["HYDROXYPROGESTERONE CAPROATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["HYDROXYPROGESTERONE CAPROATE"],"manufacturer_name":["AuroMedics Pharma LLC"],"application_number":["ANDA211142"],"is_original_packager":[true]},"version":"4","warnings":["WARNINGS Thrombotic and Thromboembolic Events Discontinue the medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Medication should be stopped if examination reveals papilledema or retinal vascular lesions. Allergic reactions Hypersensitivity reaction to progestins have been reported. Hydroxyprogesterone caproate is contraindicated in women with a history of hypersensitivity to a progestin. Glucose tolerance Progestins may decrease glucose tolerance and the blood glucose concentration should be monitored in diabetic users."],"description":["DESCRIPTION Hydroxyprogesterone Caproate Injection, USP is a sterile, long-acting preparation of the caproate ester of the naturally- occurring progestational hormone, hydroxyprogesterone, in an oil solution for intramuscular use. The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20-dione, 17[(1-oxohexyl)oxy]. It has a molecular formula of C 27 H 40 O 4 and a molecular weight of 428.60. Hydroxyprogesterone caproate exists as white or creamy white crystalline powder. The structural formula is: Each 5 mL multiple-dose vial contains hydroxyprogesterone caproate, 250 mg/mL, in castor oil (28.6% v/v) and benzyl benzoate (46 % v/v) with the preservative benzyl alcohol (2% v/v). Chemical Structure"],"precautions":["PRECAUTIONS Detectable amounts of progestins have been identified in the milk of mothers receiving the drug. Many studies have found no adverse effects of progestins on breastfeeding performance, or on the health, growth, or development of the infant. Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this effect, such as asthma, migraine, epilepsy, or cardiac or renal dysfunction require careful observation. The pretreatment physical examination should include examination of the breasts and pelvic organs and a Papanicolaou smear. In relation to irregular bleeding which does not respond predictably to the hormone therapy, nonfunctional causes should be borne in mind and adequate diagnostic measures instituted. Any influence of prolonged sex hormone medication on pituitary, ovarian, adrenal, hepatic, or uterine function awaits further study. The pathologist should be advised of progesterone therapy when relevant specimens are submitted. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. Information for The Patient Counsel patients that hydroxyprogesterone caproate injections may cause pain, soreness, swelling, itching or bruising. Inform the patient to contact her physician if she notices increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site."],"how_supplied":["HOW SUPPLIED Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. Hydroxyprogesterone Caproate Injection, USP is a sterile, clear pale yellow to yellow color oily solution and is supplied as follows: 5 mL Multiple-Dose Vial Packaged Individually NDC 55150-311-01 5 mL Multiple-Dose Vials in a carton of 5 NDC 55150-311-05 Storage Hydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25° C (68° to 77° F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water. Protect from light. Store vial in its box. Store upright. Discard any unused product within 5 weeks after first use. The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Road E.Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India Revised: June 2022"],"effective_time":"20220622","adverse_reactions":["ADVERSE REACTIONS A. Serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, have been reported in women using progestins. B. neuroocular lesions (e.g., retinal thrombosis and optic neuritis); nausea; vomiting; gastrointestinal symptoms (such as abdominal cramps or bloating); edema; breakthrough bleeding, spotting, or withdrawal bleeding; breast tenderness; changes in body weight (increase or decrease); headache; increase in cervical mucus; allergic rash; abscess; pain at the injection site; migraine headaches. C. chloasma or melasma, cholestatic jaundice, rise in blood pressure, mental depression, and amenorrhea during or after treatment. D. posttreatment anovulation, cystitis, hirsutism, loss of scalp hair, changes in libido, changes in appetite, dizziness, fatigue, backache, itching, or amenorrhea. E. The following laboratory tests may be affected by progestins: hepatic function (increased sulfobromophthalein retention and other tests); coagulation tests (increased in prothrombin and Factors VII, VIII, IX, and X); thyroid function tests (increase in PBI and butanol extractable protein-bound iodine, decrease in T3 uptake values. A few instances of coughing, dyspnea, constriction of the chest, and/or allergic-like reactions have occurred following hydroxyprogesterone caproate therapy; the likelihood of these occurring may be increased at higher dosage levels."],"contraindications":["CONTRAINDICATIONS Hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. Hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Hydroxyprogesterone is a potent, long-acting, progestational steroid ester which transforms proliferative endothelium into secretory endothelium, induces mammary gland duct development, and inhibits the production and/or release of gonadotropic hormone; it also shows slight estrogenic, androgenic, or corticoid effects as well, but should not be relied upon for these effects. In advanced adenocarcinoma of the uterine corpus, Hydroxyprogesterone Caproate Injection, USP in a dosage of 1,000 mg or more, one or more times each week, often induces regressive changes. Absorption : Peak serum levels of hydroxyprogesterone caproate appeared after 3 to 7 days in non-pregnant female subjects following a single intramuscular injection of 1,000 mg hydroxyprogesterone caproate. The pharmacokinetics of the 250 mg dose of hydroxyprogesterone caproate has not been evaluated in a study. Metabolism : The conjugated metabolites include sulfated and glucuronidated products. In vitro data indicate that the metabolism of hydroxyprogesterone caproate is predominantly mediated by CYP3A4 and CYP3A5. Excretion : Both conjugated metabolites and free steroids are excreted in the urine and feces, with the conjugated metabolites being prominent. Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of hydroxyprogesterone caproate has not been evaluated. Hydroxyprogesterone caproate is extensively metabolized and hepatic impairment may reduce the elimination of hydroxyprogesterone caproate. Renal Impairment The effect of renal impairment on the pharmacokinetics of hydroxyprogesterone caproate has not been evaluated."],"indications_and_usage":["INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation."],"information_for_patients":["Information for The Patient Counsel patients that hydroxyprogesterone caproate injections may cause pain, soreness, swelling, itching or bruising. Inform the patient to contact her physician if she notices increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Suggested dosages are presented in the therapy guide. Because of the low viscosity of the vehicle, Hydroxyprogesterone Caproate Injection, USP may be administered with a small gauge needle. Care should be taken to inject the preparation deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection. Since the 250 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose. Note: Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Protect from light. Store vial in its box. Store upright. Discard any unused product within 5 weeks after first use. THERAPY GUIDE CYCLIC THERAPY SCHEDULE: (28-day cycle; repeated every 4 weeks); Day 1 of each cycle: 20 mg Estradiol Valerate Injection, USP 2 weeks after Day 1: 250 mg Hydroxyprogesterone Caproate Injection, USP and 5 mg Estradiol Valerate Injection, USP 4 weeks after Day 1. This is Day 1 of next cycle SUGGESTED CYCLIC REGIMEN Indications Dosage Started Repeated Stopped Comments Amenorrhea (primary and secondary): Abnormal uterine bleeding due to hormonal imbalance in the absence of organicpathology, such as submucous fibroids or uterine cancer. 375 mg Any time - - Genital malignancy should be excluded before hormone therapy is started. Hydroxyprogesterone caproate is used as a “Medical D and C” to eliminate any proliferated endometrium from previous estrogenic action by conversion to secretory endometrium and desquamation. To determine onset of normal cyclic functions, patient should be observed for 2 or 3 cycles after cessation of therapy. Cyclic Therapy Schedule After 4 days of desquamation or, if there is no bleeding, 21 days after Hydroxyprogesterone Caproate Injection, USP alone Every 4 weeks After 4 cycles Production of secretory endometrium and desquamation Patients not on estrogen therapy: Cyclic Therapy Schedule Any time Every 4 weeks When cyclic therapy is no longer required If estrogen deficiency has been prolonged, menstruation may not occur until estrogen has been given for several months. Patients currently on estrogen therapy: 375 mg Hydroxy progesterone Caproate Injection, USP Any time - - Cyclic Therapy Schedule After 4 days of desquamation or, if there is no bleeding, 21 days after Hydroxyprogesterone Caproate Injection, USP alone Every 4 weeks When cyclic therapy is no longer required SUGGESTED NON-CYCLIC REGIMEN Indications Dosage Started Repeated Stopped Comments Adenocarcinoma of uterine corpus in advanced stage (Stage III or IV) 1,000 mg or more At once 1 or more times each week (1 to 7 g per week) When relapse occurs, or after 12 weeks with no objective response Should not be used in early stage (Stage I or II) in place of established anticancer therapy. May be used in advanced stage concomitantly with other anticancer therapy (surgery, α radiation, or chemotherapy, or combination of these). Treatment results reported to date have been better in histologically well-differentiated forms of endometrial adenocarcinoma. (The drug has not been adequately studied in non-endometrioid adenocarcinoma of the uterine corpus). Test for endogenous estrogen production (\"Medical D and C\") 250 mg Any time For confirmation, 4 weeks after 1 st injection After 2 nd injection Non-pregnant patient with responsive endometrium; bleeding 7 to14 days after injection indicates endogenous estrogen."],"spl_product_data_elements":["Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CASTOR OIL BENZYL BENZOATE BENZYL ALCOHOL"],"dosage_and_administration_table":["
SUGGESTED CYCLIC REGIMEN
Indications Dosage Started Repeated Stopped Comments
Amenorrhea (primary and secondary): Abnormal uterine bleeding due to hormonal imbalance in the absence of organicpathology, such as submucous fibroids or uterine cancer. 375 mg Any time - - Genital malignancy should be excluded before hormone therapy is started. Hydroxyprogesterone caproate is used as a “Medical D and C” to eliminate any proliferated endometrium from previous estrogenic action by conversion to secretory endometrium and desquamation. To determine onset of normal cyclic functions, patient should be observed for 2 or 3 cycles after cessation of therapy.
Cyclic Therapy Schedule After 4 days of desquamation or, if there is no bleeding, 21 days after Hydroxyprogesterone Caproate Injection, USP alone Every 4 weeks After 4 cycles
Production of secretory endometrium and desquamation Patients not on estrogen therapy: Cyclic Therapy Schedule Any time Every 4 weeks When cyclic therapy is no longer required If estrogen deficiency has been prolonged, menstruation may not occur until estrogen has been given for several months.
Patients currently on estrogen therapy: 375 mg Hydroxy progesterone Caproate Injection, USP Any time - -
Cyclic Therapy Schedule After 4 days of desquamation or, if there is no bleeding, 21 days after Hydroxyprogesterone Caproate Injection, USP alone Every 4 weeks When cyclic therapy is no longer required
","
SUGGESTED NON-CYCLIC REGIMEN
Indications DosageStartedRepeatedStoppedComments
Adenocarcinoma of uterine corpus in advanced stage (Stage III or IV) 1,000 mg or more At once1 or more times each week (1 to 7 g per week)When relapse occurs, or after 12 weeks with no objective responseShould not be used in early stage (Stage I or II) in place of established anticancer therapy. May be used in advanced stage concomitantly with other anticancer therapy (surgery, α radiation, or chemotherapy, or combination of these). Treatment results reported to date have been better in histologically well-differentiated forms of endometrial adenocarcinoma. (The drug has not been adequately studied in non-endometrioid adenocarcinoma of the uterine corpus).
Test for endogenous estrogen production ("Medical D and C")250 mgAny timeFor confirmation, 4 weeks after 1st injectionAfter 2nd injectionNon-pregnant patient with responsive endometrium; bleeding 7 to14 days after injection indicates endogenous estrogen.
"],"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) - Container Label Rx only NDC 55150-311-01 Hydroxyprogesterone Caproate Injection, USP 1,250 mg per 5 mL (250 mg / mL) For Intramuscular Use Only 5 mL Multiple Dose Vial AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) - Container Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (1 vial) Rx only NDC 55150-311-01 Hydroxyprogesterone Caproate Injection, USP 1,250 mg per 5 mL (250 mg / mL) For Intramuscular Use Only 5 mL Multiple Dose Vial AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (1 vial)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (5 vials) Rx only NDC 55150-311-05 Hydroxyprogesterone Caproate Injection, USP 1,250 mg per 5 mL (250 mg / mL) For Intramuscular Use Only 5 x 5 mL Multiple Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (5 vials)"]},"tags":[{"label":"Progestin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Corticosteroid-binding globulin","category":"target"},{"label":"SERPINA6","category":"gene"},{"label":"PGR","category":"gene"},{"label":"NR3C1","category":"gene"},{"label":"G03DA03","category":"atc"},{"label":"Intramuscular","category":"route"},{"label":"Subcutaneous","category":"route"},{"label":"Injection","category":"form"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Prevention of Premature Labor","category":"indication"},{"label":"Bristol Myers Squibb","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Estrogen Antagonists","category":"pharmacology"},{"label":"Hormone Antagonists","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"},{"label":"Progestins","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":5591.902,"date":"","count":1335,"signal":"Premature baby","source":"DrugCentral FAERS","actionTaken":"Reported 1,335 times (LLR=5592)"},{"llr":2174.03,"date":"","count":610,"signal":"Injection site pruritus","source":"DrugCentral FAERS","actionTaken":"Reported 610 times (LLR=2174)"},{"llr":1931.936,"date":"","count":740,"signal":"Injection site pain","source":"DrugCentral FAERS","actionTaken":"Reported 740 times (LLR=1932)"},{"llr":1879.03,"date":"","count":296,"signal":"Preterm premature rupture of membranes","source":"DrugCentral FAERS","actionTaken":"Reported 296 times (LLR=1879)"},{"llr":1333.395,"date":"","count":200,"signal":"Uterine contractions during pregnancy","source":"DrugCentral FAERS","actionTaken":"Reported 200 times (LLR=1333)"},{"llr":963.231,"date":"","count":240,"signal":"Premature labour","source":"DrugCentral FAERS","actionTaken":"Reported 240 times (LLR=963)"},{"llr":845.674,"date":"","count":201,"signal":"Stillbirth","source":"DrugCentral FAERS","actionTaken":"Reported 201 times (LLR=846)"},{"llr":843.186,"date":"","count":249,"signal":"Injection site mass","source":"DrugCentral FAERS","actionTaken":"Reported 249 times (LLR=843)"},{"llr":760.251,"date":"","count":284,"signal":"Injection site swelling","source":"DrugCentral FAERS","actionTaken":"Reported 284 times (LLR=760)"},{"llr":596.061,"date":"","count":202,"signal":"Premature delivery","source":"DrugCentral FAERS","actionTaken":"Reported 202 times (LLR=596)"},{"llr":595.144,"date":"","count":276,"signal":"Injection site erythema","source":"DrugCentral FAERS","actionTaken":"Reported 276 times (LLR=595)"},{"llr":513.934,"date":"","count":86,"signal":"Cervical incompetence","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=514)"},{"llr":492.755,"date":"","count":196,"signal":"Abortion spontaneous","source":"DrugCentral FAERS","actionTaken":"Reported 196 times (LLR=493)"},{"llr":481.273,"date":"","count":299,"signal":"Inappropriate schedule of product administration","source":"DrugCentral FAERS","actionTaken":"Reported 299 times (LLR=481)"},{"llr":439.835,"date":"","count":67,"signal":"Shortened cervix","source":"DrugCentral FAERS","actionTaken":"Reported 67 times (LLR=440)"}],"drugInteractions":[{"url":"/drug/cyp2a6-substrates","drug":"CYP2A6 Substrates","action":"Use caution","effect":"Strong CYP2A6 Inducers - CYP2A6 Substrates","source":"DrugCentral","drugSlug":"cyp2a6-substrates"}],"commonSideEffects":[{"effect":"coughing","drugRate":"reported","severity":"unknown"},{"effect":"dyspnea","drugRate":"reported","severity":"unknown"},{"effect":"constriction of the chest","drugRate":"reported","severity":"unknown"},{"effect":"allergic-like reactions","drugRate":"reported","severity":"unknown"}],"contraindications":["Asthma","Body fluid retention","Carcinoma of female breast","Chronic heart failure","Deep venous thrombosis","Depressive disorder","Diabetes mellitus","Disease of liver","Epilepsy","Hyperglycemia","Hypertensive disorder","Impaired glucose tolerance","Intermenstrual bleeding - irregular","Jaundice","Kidney disease","Migraine","Mild pre-eclampsia","Neoplasm of liver","Predisposition to Thrombosis","Seizure disorder","Thromboembolic disorder"],"specialPopulations":{"Lactation":"Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate. Published studies have reported no adverse effects of progestins on the breastfed child or on milk production.","Pregnancy":"Makena is indicated to reduce the risk of preterm birth in women with singleton pregnancy who have history of singleton spontaneous preterm birth. Data from the placebo-controlled clinical trial and the infant follow-up safety study did not show difference in adverse developmental outcomes between children of Makena-treated women and children of control subjects.","Geriatric use":"Hydroxyprogesterone caproate injection is not intended for use in postmenopausal women. Safety and effectiveness in postmenopausal women have not been established.","Paediatric use":"Makena is not indicated for use in women under 16 years of age. Safety and effectiveness in patients less than 16 years of age have not been established."}},"trials":[],"aliases":[],"company":"Bristol-Myers Squibb","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HYDROXYPROGESTERONE CAPROATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:26:50.434928+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Hydroxyprogesterone Caproate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:26:57.152409+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:26:55.799990+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDROXYPROGESTERONE CAPROATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:26:55.976507+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:26:49.238527+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:26:49.238552+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Progesterone receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:26:57.152365+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200848/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:26:56.818189+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA211142","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:26:49.238556+00:00"}},"allNames":"delalutin","offLabel":[],"synonyms":["oxyprogesterone caproate","17-alpha-hydroxy-progesterone caproate","delalutin","17alpha-hydroxyprogesterone","makena","17alpha-Hydroxyprogesterone hexanoate","hydroxyprogesterone hexanoate","progesterone caproate","gestageno","hydroxyprogesterone caproate"],"timeline":[{"date":"1975-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ACTAVIS LABS UT INC to Bristol Myers Squibb"},{"date":"1975-10-03","type":"positive","source":"DrugCentral","milestone":"FDA approval (Actavis Labs Ut Inc)"},{"date":"2015-08-24","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"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.","approvals":[{"date":"1975-10-03","orphan":false,"company":"ACTAVIS LABS UT INC","regulator":"FDA"}],"brandName":"Delalutin","ecosystem":[{"indication":"Prevention of Premature Labor","otherDrugs":[{"name":"progesterone","slug":"progesterone","company":"Alza"}],"globalPrevalence":null}],"mechanism":{"target":"Corticosteroid-binding globulin","novelty":"Follow-on","targets":[{"gene":"SERPINA6","source":"DrugCentral","target":"Corticosteroid-binding globulin","protein":"Corticosteroid-binding globulin"},{"gene":"PGR","source":"DrugCentral","target":"Progesterone receptor","protein":"Progesterone receptor"},{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"},{"gene":"SHBG","source":"DrugCentral","target":"Sex hormone-binding globulin","protein":"Sex hormone-binding globulin"},{"gene":"ADORA3","source":"DrugCentral","target":"Adenosine receptor A3","protein":"Adenosine receptor A3"},{"gene":"MAPK3","source":"DrugCentral","target":"Mitogen-activated protein kinase 3","protein":"Mitogen-activated protein kinase 3"},{"gene":"SLC6A3","source":"DrugCentral","target":"Sodium-dependent dopamine transporter","protein":"Sodium-dependent dopamine transporter"}],"modality":"Small Molecule","drugClass":"Progestin","explanation":"","oneSentence":"","technicalDetail":"Delalutin (hydroxyprogesterone caproate) is a progestin that binds to corticosteroid-binding globulin (CBG), a plasma protein that transports cortisol and other corticosteroids. By binding to CBG, Delalutin increases the concentration of free cortisol in the bloodstream, which helps to maintain pregnancy and prevent premature labor."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Hydroxyprogesterone_caproate","title":"Hydroxyprogesterone caproate","extract":"Hydroxyprogesterone caproate, sold under the brand name Delalutin among others, is a medication used to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. In March 2023, the manufacturer, Covis Pharma, agreed to withdraw the drug from the US market. The approval of this drug substance was withdrawn by the US Food and Drug Administration (FDA) in April 2023. In May 2024, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended suspending the marketing authorizations of medications containing 17-hydroxyprogesterone caproate in the European Union.","wiki_history":"==History==\nAlong with hydroxyprogesterone acetate, hydroxyprogesterone caproate was developed by Karl Junkmann of Schering AG in 1953 and was first reported by him in the medical literature in 1954. It was reportedly first marketed in Japan in 1954 or 1955, and was subsequently introduced as Delalutin in the United States in 1956. Due to its much longer duration than parenteral progesterone, hydroxyprogesterone caproate had largely replaced progesterone in clinical practice by 1975. After decades of use, Squibb, the manufacturer, voluntarily withdrew the Delalutin product in the United States in 1999.\n\nUnder the FDA Accelerated Approval Programs, drugs that fill an unmet need for serious conditions can be approved based on a surrogate endpoint. The pharmaceutical company is required to conduct confirmatory studies to show the drug provides a clinical benefit. The confirmatory trial, the PROLONG study, was completed in 2019 and showed no benefit in preventing preterm birth. The FDA proposed withdrawal of approval for Makena in 2020.","wiki_society_and_culture":"==Society and culture==\n\n=== Names ===\nHydroxyprogesterone caproate is the generic name of OHPC and its , , , and , while hydroxyprogesterone hexanoate was its former . It should also not be confused with hydroxyprogesterone acetate, hydroxyprogesterone heptanoate, or medroxyprogesterone acetate. It is not available in Canada, the United Kingdom, New Zealand, or South Africa, and only veterinary formulations are available in Australia. The FDA subsequently announced that compounding pharmacies could continue to sell hydroxyprogesterone caproate at their usual cost of approximately to per dose without fear of enforcement action by the agency. KV Pharmaceutical also opted to reduced its price of Makena to per dose. Hydroxyprogesterone caproate continued to be available at low cost from compounding pharmacies until late 2016, after which time the FDA published new guidance documents prohibiting compounding pharmacies from selling products that are \"essentially copies\" of commercially available drug products."},"commercial":{"launchDate":"1975","_launchSource":"DrugCentral (FDA 1975-10-03, ACTAVIS LABS UT INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4189","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=HYDROXYPROGESTERONE%20CAPROATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDROXYPROGESTERONE CAPROATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Hydroxyprogesterone_caproate","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T13:54:22.757316","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:26:59.601197+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"medroxyprogesterone","drugSlug":"medroxyprogesterone","fdaApproval":"1959-06-18","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"progesterone","drugSlug":"progesterone","fdaApproval":"1976-02-04","patentExpiry":"Jan 21, 2030","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"hydroxyprogesterone caproate","indications":{"approved":[{"name":"Prevention of Premature Labor","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"non-pregnant women"}],"offLabel":[{"name":"Endometrial carcinoma","source":"DrugCentral","drugName":"HYDROXYPROGESTERONE CAPROATE","evidenceCount":60,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Bristol Myers Squibb","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"medroxyprogesterone","brandName":"medroxyprogesterone","genericName":"medroxyprogesterone","approvalYear":"1959","relationship":"same-class"},{"drugId":"progesterone","brandName":"progesterone","genericName":"progesterone","approvalYear":"1976","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02913495","phase":"PHASE4","title":"Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth","status":"COMPLETED","sponsor":"Thomas Jefferson University","startDate":"2016-09","conditions":["Premature Birth"],"enrollment":210,"completionDate":"2021-09"},{"nctId":"NCT07307092","phase":"NA","title":"Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage","status":"COMPLETED","sponsor":"Hina Mukhtar","startDate":"2021-10-26","conditions":["Preterm Labour","Cervical Insufficiency","Pregnancy, High-Risk"],"enrollment":820,"completionDate":"2022-04-25"},{"nctId":"NCT03257462","phase":"PHASE2","title":"Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia","status":"COMPLETED","sponsor":"Spruce Biosciences","startDate":"2017-07-12","conditions":["Congenital Adrenal Hyperplasia","CAH - Congenital Adrenal Hyperplasia"],"enrollment":24,"completionDate":"2019-03-29"},{"nctId":"NCT03292731","phase":"PHASE1,PHASE2","title":"Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth","status":"TERMINATED","sponsor":"Steve N. 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