Hydroxyprogesterone Caproate

Overview

Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999. The U.S. FDA approved Makena from KV Pharmaceutical (previously named as Gestiva) on February 4, 2011 for prevention of preterm delivery in women with a history of preterm delivery, sparking a pricing controversy. In April 2023, the FDA withdrew its approval of Makena and its generics given an unfavorable risk-to-benefit assessment.

Indication

本品与戊酸雌二醇配伍作长效注射避孕药，具有排卵抑制作用，每月肌内注射一次，避孕效果肯定。

Associated Conditions

Corpus Luteum Insufficiency
Premature Births
Primary Amenorrhoea
Secondary Amenorrhea

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders	2021/03/15	NCT04797338	Phase 4	UNKNOWN	Assaf-Harofeh Medical Center
Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa	2018/12/19	NCT03779451	Not Applicable	UNKNOWN	Aswan University Hospital
17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa	2018/12/19	NCT03779438	Not Applicable	UNKNOWN	Aswan University Hospital
Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women	2016/10/21	NCT02940522	Phase 1	Completed	AMAG Pharmaceuticals, Inc.
Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women	2016/10/19	NCT02937766	Phase 3	Terminated	AMAG Pharmaceuticals, Inc.
Study of Pharmacology of 17-OHPC in Pregnancy	2006/12/11	NCT00409825	Phase 2	Completed	University of Pittsburgh

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Hydroxyprogesterone Caproate	Mylan Institutional LLC	67457-886	INTRAMUSCULAR	250 mg in 1 mL	11/15/2021
Hydroxyprogesterone Caproate	Amneal Pharmaceuticals of NY LLC	69238-1797	INTRAMUSCULAR	250 mg in 1 mL	8/1/2018
Hydroxyprogesterone Caproate	AuroMedics Pharma LLC	55150-311	INTRAMUSCULAR	1250 mg in 5 mL	6/22/2022
Hydroxyprogesterone Caproate	American Regent, Inc.	0517-1767	INTRAMUSCULAR	250 mg in 1 mL	7/1/2018
HYDROXYPROGESTERONE CAPROATE	Sun Pharmaceutical Industries, Inc.	47335-037	INTRAMUSCULAR	250 mg in 1 mL	4/18/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PROLUTON DEPOT INJECTION 250MG/ML	Bayer AG (Berlin, Müllerstraβe)	SIN14879P	INJECTION	0.250g/ml	10/27/2015

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

AI-Powered Research

Premium Access