Drugs / 17-alpha-hydroxyprogesterone caproate
17-alpha-hydroxyprogesterone caproate
also known as
Hydroxyprogesterone Caproate · 17-OHPC · 17P · 17-OHP · 17α-hydroxyprogesterone caproate · 17 Hydroxyprogesterone Capronate · HPC
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | HYDROXYPROGESTERONE CAPROATE | — | 1980-01-23 – 1981-03-23 | fda.gov ↗ |
| Approved | US (FDA) | HYDROXYPROGESTERONE CAPROATE | — | 1974-12-26 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01899846 | Jul 2013 → Aug 2014 | pregnancy disorder | Lumara Health, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02989025 | May 2017 → Jan 2027 expected | preeclampsia | University of Mississippi Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT00409825 | Mar 2006 → Apr 2008 | pregnancy disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT00099164 | Apr 2004 → Aug 2006 | pregnancy disorder, preterm premature rupture of the membranes | The George Washington University Biostatistics Center | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04077853 | Dec 2019 → Oct 2021 | preeclampsia | Assiut University | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT07307092 | Oct 2021 → Apr 2022 | cervical incompetence | Hina Mukhtar | Completed | No outcome recorded |
| — | NCT00579553 | Oct 2006 → May 2011 | — | University of Oklahoma | Completed | Missed primary |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT02940522 Comparator | Sep → Dec 2016 | — | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00141908 Comparator | Oct 2006 → Dec 2012 | — | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT01119963 Comparator | Oct 2011 → Apr 2014 | preterm premature rupture of the membranes | Obstetrix Medical Group | Completed | No outcome recorded |
| Phase 2/3 | NCT00163020 Comparator | Nov 2004 → Aug 2009 | — | Obstetrix Medical Group | Completed | No outcome recorded |
| Phase 3 | NCT02937766 Comparator | Oct 2016 → Jan 2017 | — | AMAG Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02304237 Comparator | Dec 2014 → Nov 2016 | — | Ewha Womans University Mokdong Hospital | Unknown | Met primary |
| Phase 3 | NCT01178788 Comparator | Feb 2010 → Dec 2015 | — | University of Modena and Reggio Emilia | Completed | No outcome recorded |
| Phase 3 | NCT01004029 Comparator | Oct 2009 → Oct 2018 | — | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00439374 Comparator | Apr 2007 → May 2011 | — | The George Washington University Biostatistics Center | Terminated | No outcome recorded |
| Phase 3 | NCT00135902 Comparator | Feb 2005 → Mar 2007 | — | The George Washington University Biostatistics Center | Completed | No outcome recorded |
| Phase 4 | NCT04797338 Comparator | Dec 2017 → Sep 2021 | ovarian hyperstimulation syndrome, pregnancy disorder with abortive outcome | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| — | NCT03779451 Comparator | Jan 2019 → Dec 2021 | placenta praevia | Aswan University Hospital | Unknown | No outcome recorded |
| — | NCT03779438 Comparator | Jan 2019 → Dec 2021 | placenta praevia | Aswan University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-06-14 | Covis Pharma S.à.r.l. | Regulatory Covis Pharma Provides Update on FDA Public Hearing for Makena® covispharma.com ↗
FDA’s announcement of the anticipated hearing date is the latest development following FDA’s August 2021 order granting a hearing on its proposal to withdraw approval of Makena and its five generic versions. |
| 2021-08-19 | Covis Pharma S.à.r.l. | Regulatory Covis Pharma Announces FDA’s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients covispharma.com ↗ |
| 2021-03-26 | Covis Pharma S.à.r.l. | Results EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies covispharma.com ↗
EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies |
| 2020-12-14 | Covis Pharma S.à.r.l. | Regulatory AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection) covispharma.com ↗
AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection) |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-14 | Covis Pharma S.à.r.l. | Covis Pharma Provides Update on FDA Public Hearing for Makena® covispharma.com ↗ |
| 2021-08-19 | Covis Pharma S.à.r.l. | Covis Pharma Announces FDA’s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients covispharma.com ↗ |
| 2021-03-26 | Covis Pharma S.à.r.l. | EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies covispharma.com ↗ |
| 2020-12-14 | Covis Pharma S.à.r.l. | AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection) covispharma.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 17 alpha-hydroxyprogesterone-caproate | “Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with...” NCT04077853 ↗13“Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with...” NCT03779438 ↗ “Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.” NCT00135902 ↗ “Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P” NCT00579553 ↗ “group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week)” NCT03779451 ↗ “17-alpha hydroxyprogesterone caproate, Makena®” NCT01119963 ↗ “17 alpha-hydroxyprogesterone caproate (17P)” NCT00099164 ↗ “17-alpha-hydroxyprogesterone caproate” NCT00409825 ↗ |
| Known as | 17 Hydroxyprogesterone Capronate | “Drug: 17 Hydroxyprogesterone Capronate” NCT04077853 ↗ |
| Known as | 17-OHP | “Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce...” NCT00163020 ↗1“17 alpha-hydroxyprogesterone caproate (17-OHP) reduces preterm birth (PTB)” PMID 23010094 ↗ Sep 2012 |
| Known as | 17-OHPC | “Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with...” NCT04077853 ↗5“To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due...” PMID 31652479 ↗ Oct 2019 |
| Known as | 17P | “It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%.” NCT00439374 ↗2“Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P” NCT00579553 ↗ “17 alpha-hydroxyprogesterone caproate (17P)” NCT00099164 ↗ |
| Known as | 17α-hydroxyprogesterone caproate | “To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due...” PMID 31652479 ↗ Oct 20191“17α-hydroxyprogesterone caproate weekly (IM group)” PMID 32536019 ↗ Jul 2020 |
| Known as | HPC | “Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL” NCT01004029 ↗ |
| Known as | Hydroxyprogesterone Caproate | “Hydroxyprogesterone caproate 250 mg administered intramuscularly once weekly from 16 to 36 weeks of gestation following cervical cerclage. Used to maintain uterine quiescence...” NCT07307092 ↗6“hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes” NCT02304237 ↗ |
| Route | Intramuscular | “weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo” PMID 19155896 ↗ Feb 2009 |