carboprost tromethamine

Trade name: hemabate

Small moleculeapproved

Approved

Jan 9, 1979

Carboprost is an analogue of naturally occurring prostaglandin F2alpha. Administered intramuscularly carboprost stimulates in the gravid uterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. It is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and for the treatment of postpartum hemorrhage due to uterine atony, which has not responded to conventional methods of management. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle: vomiting, diarrhea, nausea, fever and flushing. Carboprost may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended. — NCATS

Clinical trial activity

5 trials · 14 clinical orgs · 17 marketing orgs

Phase 1
1
Phase 2
0
Phase 3
0
Phase 4
0

Earliest trial started Jun 1, 2007 (NCT00989027)

Timeline

1970s

  1. Jan 9, 1979

    Pharmacia & Upjohn — Earliest FDA Approval

  2. Jan 9, 1979

    Pharmacia & Upjohn — NDA Secondary Org

  3. Jan 9, 1979

    Pharmacia & Upjohn — NDA Organization

  4. Jan 9, 1979

    Pfizer — Marketing Organization

  5. Jan 9, 1979

    Pfizer — NDA Secondary Org

2010s

  1. Jul 2, 2019

    Dr. Reddy's Laboratories — Marketing Organization

2020s

  1. Mar 25, 2021

    Sunny Pharmtech Inc — Marketing Organization

  2. Jan 1, 2022

    Earliest Phase 1 Sponsor(trial)

  3. Jan 27, 2022

    Amneal Pharmaceuticals — Marketing Organization

  4. Aug 9, 2022

    LONG GROVE PHARMS — Marketing Organization

  5. Feb 13, 2023

    Caplin Point Laboratories — Marketing Organization

  6. May 19, 2023

    Sola Pharms — Marketing Organization

  7. May 25, 2023

    Eugia Pharma — Marketing Organization

  8. Jun 15, 2023

    Alembic — Marketing Organization

  9. Jul 25, 2023

    STERISCIENCE — Marketing Organization

  10. Jul 25, 2023

    ONESOURCE SPECIALTY — Marketing Organization

  11. Aug 7, 2023

    Gland Pharma Ltd — Marketing Organization

  12. Aug 7, 2023

    Fosun — Marketing Organization

  13. Jan 25, 2024

    Ani Pharmaceuticals — Marketing Organization

  14. Apr 3, 2024

    Micro Labs Ltd India — Marketing Organization

  15. May 27, 2026

    Somerset Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJan 9, 1979

Chemistry & pharmacology

Loading structure…

SMILES

CCCCC[C@](C)(O)/C=C/[C@@H]1[C@@H](C/C=C\CCCC(=O)O)[C@@H](O)C[C@H]1O
Mol. weight
368.51 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 1,3-dihydroxy-2-(hydroxymethyl)propan-2-aminium (5z,9alpha,11beta,13e,15s)-9,11,15-trihydroxy-15-methylprosta-5,13-dien-1-oate
  • 1,3-dihydroxy-2-(hydroxymethyl)propan-2-aminium (5z,9alpha,11beta,13e,15s)-9,11,15-trihydroxy-15-methylprosta-5,13-dien-1-oate
  • 15-methylprostaglandin f2alpha-tromethamine
  • (15s)-15-methyl-pgf2alpha tromethamine salt
  • (15s)-15-methyl-pgf2alpha tromethamine salt
  • 15(s)-15-methyl-pgf2alpha tromethamine salt
  • 15(s)-15-methyl-pgf2alpha tromethamine salt
  • (15s)-15-methylprostaglandin f2alpha tromethamine
  • (15s)-15-methylprostaglandin f2alpha tromethamine
  • 15(s)-15-methylprostaglandin f2alpha tromethamine
  • 15(s)-15-methylprostaglandin f2alpha tromethamine
  • carboprost
  • carboprost
  • carboprost
  • carboprost
  • carboprost
  • carboprost
  • carboprost
  • carboprost
  • carboprost
  • carboprost trometamol
  • carboprost trometamol
  • carboprost trometamol
  • carboprost trometamol
  • carboprost trometanol
  • carboprost trometanol
  • carboprost tromethamine
  • carboprost tromethamine
  • carboprost tromethamine
  • carboprost tromethamine
  • carboprost tromethamine
  • carboprost tromethamine
  • carboprost tromethamine
  • carboprost tromethamine
  • hemabate
  • hemabate
  • hemabate
  • hemabate
  • methyldinoprost
  • methyldinoprost
  • prostin m-15
  • u-32921
  • u-32921
  • u-32921e
  • u-32921e

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06285409N/AApr 4, 2024Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, Canada
NCT05518812Early Phase 1 (Phase 1)Jul 12, 2022Northwestern University
NCT02861482N/AJan 1, 2015Dongguan Maternity & Child Health Hospital, Guangzhou Medical University, Guangzhou University, Jiangmen Maternity & Child Health Care Hospital, Nanhai Maternity & Child Healthcare Hospital, Shenzhen University, Southern Medical University, Sun Yat-Sen University, The First Maternity & Child Healthcare Hospital of Huizhou, Xiaolan People's Hospital of Zhongshan, Zhongshan Dongsheng hospital
NCT01869556N/AMay 1, 2013Icahn School of Medicine at Mount Sinai
NCT00989027N/AJun 1, 2007Icahn School of Medicine at Mount Sinai
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (14)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Icahn School of Medicine at Mount SinaiAcademic/Hospital3312007
Dongguan Maternity & Child Health HospitalAcademic/Hospital1012015
Guangzhou Medical UniversityAcademic/Hospital1012015
Guangzhou UniversityAcademic/Hospital1012015
Jiangmen Maternity & Child Health Care HospitalAcademic/Hospital1012015
Mount Sinai Hospital, CanadaAcademic/Hospital1012024
Nanhai Maternity & Child Healthcare HospitalAcademic/Hospital1012015
Northwestern UniversityAcademic/Hospital1112022
Shenzhen UniversityAcademic/Hospital1012015
Southern Medical UniversityAcademic/Hospital1012015
Sun Yat-Sen UniversityAcademic/Hospital1112015
The First Maternity & Child Healthcare Hospital of HuizhouAcademic/Hospital1012015
Xiaolan People's Hospital of ZhongshanAcademic/Hospital1012015
Zhongshan Dongsheng hospitalAcademic/Hospital1012015
14 organizations
Page 1 / 1

Marketing (23)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGJun 15, 2023
Amneal PharmaceuticalsFor profitMKTGJan 27, 2022
Ani PharmaceuticalsFor profitMKTGJan 25, 2024
Caplin Point LaboratoriesFor profitMKTGFeb 13, 2023
Dr. Reddy's LaboratoriesFor profitSYNJul 2, 2019
Dr. Reddy's LaboratoriesFor profitMKTGJul 2, 2019
Eugia PharmaFor profitMKTGMay 25, 2023
FosunFor profitMKTGAug 7, 2023
Gland Pharma LtdFor profitMKTGAug 7, 2023
Gland Pharma LtdFor profitSYNAug 7, 2023
LONG GROVE PHARMSFor profitMKTGAug 9, 2022
Micro Labs Ltd IndiaFor profitMKTGApr 3, 2024
ONESOURCE SPECIALTYFor profitMKTGJul 25, 2023
PfizerFor profitMKTGJan 9, 1979
PfizerFor profitNDA2Jan 9, 1979
Pharmacia & UpjohnFor profitNDA2Jan 9, 1979
Pharmacia & UpjohnFor profitNDAJan 9, 1979
STERISCIENCEFor profitMKTGJul 25, 2023
STERISCIENCEFor profitSYNJul 25, 2023
Sola PharmsFor profitMKTGMay 19, 2023
Somerset PharmaceuticalsFor profitMKTGMay 27, 2026
Sunny Pharmtech IncFor profitMKTGMar 25, 2021
Sunny Pharmtech IncFor profitMKTGMar 25, 2021