Drugs / Prochlorperazine
Prochlorperazine
also known as
Compazine · Buccastem · Buccastem m · Compro · PCZ · Prochlorperazine dimaleate · prochlorperazine maleate · Prochlorperazine mesylate · +6 more
Small molecule targets DRD2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COMPAZINE | — | 1956-10-23 | fda.gov ↗ |
Trials 15
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00543062 | Oct → Dec 2007 | poisoning | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00610727 | Aug → Oct 2004 | migraine disorder | Nova Pneuma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00992472 | — | — | Padagis LLC | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06450899 | Aug 2024 | acute mountain sickness | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT00422812 | Apr 2006 → Jan 2007 | migraine disorder | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00610428 | Mar → Oct 2005 | migraine disorder | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT03367572 | Apr 2018 → Apr 2024 | breast carcinoma | University of Rochester NCORP Research Base | Completed | No outcome recorded |
| Phase 3 | NCT02779959 | Apr 2016 → Oct 2017 | migraine disorder | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00475085 | Dec 2006 → Dec 2012 | — | Joseph Roscoe | Completed | Mixed |
| Phase 3 | NCT00020657 | Jul 2001 → Oct 2004 | cancer of unknown primary site | Gary Morrow | Completed | Missed primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT06310642 | May 2021 → Mar 2023 | acute mountain sickness | CHRISTUS Health | Completed | No outcome recorded |
| Phase 4 | NCT04255420 | Feb 2020 → May 2021 | headache disorder | Kendall Healthcare Group, Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT00364806 | Aug 2006 → Mar 2007 | migraine disorder | Montefiore Medical Center | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01843868 | Jan 2012 → Jun 2015 | non-Hodgkin lymphoma | Australasian Leukaemia and Lymphoma Group | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00573599 | Feb → May 2007 | migraine disorder | United States Naval Medical Center, Portsmouth | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT05013437 Background | Sep → Dec 2023 | plasma cell myeloma | Koen van Besien | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02858310 Background | Jan 2017 → Jul 2025 | cervical intraepithelial neoplasia, human papilloma virus infection, in situ carcinoma, vulvar neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT06083571 Background | Jan 2024 → Dec 2025 | migraine disorder | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04109885 Comparator | Sep 2020 → Jan 2024 | headache disorder | Christian Fromm, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01785459 Comparator | Oct 2013 → Jul 2016 | — | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00711555 Background | Nov 2005 → Nov 2008 | — | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00590317 Comparator | Mar 2005 → Sep 2008 | — | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT00001337 Background | May 1993 → May 2024 | Burkitt lymphoma, anaplastic large cell lymphoma, mediastinal gray zone lymphoma, primary mediastinal large B-cell lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT06904287 Background | Dec 2025 → Jun 2027 expected | migraine disorder | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT04503668 Background | Dec 2020 → Jan 2024 | female reproductive organ cancer | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 3 | NCT05967442 Comparator | Aug 2019 → Mar 2020 | migraine disorder | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03984045 Comparator | Jun 2019 → Jun 2022 | migraine disorder, neuralgia | Newark Beth Israel Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02735343 Comparator | Aug 2016 → May 2017 | headache disorder | Mike O'Callaghan Military Hospital | Terminated | Missed primary |
| Phase 4 | NCT03435003 Background | Aug 2017 → Mar 2019 | — | Stony Brook University | Completed | No outcome recorded |
| Phase 4 | NCT03185130 Background | May 2017 → May 2019 | headache disorder | University Medical Center of Southern Nevada | Completed | No outcome recorded |
| Phase 4 | NCT02657031 Comparator | Mar 2016 → Mar 2017 | headache disorder | University Medical Center of Southern Nevada | Completed | No outcome recorded |
| Phase 4 | NCT02389829 Comparator | Mar 2015 → Jun 2016 | migraine disorder | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01629329 Comparator | Nov 2010 → Apr 2014 | migraine disorder | Albert Einstein Healthcare Network | Terminated | No outcome recorded |
| — | NCT06182098 Background | Jun 2023 → Jun 2025 | migraine disorder | Dayton Children's Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-03-20 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg |
| 2022-08-11 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Prochlorperazine Maleate Tablets zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Prochlorperazine Maleate tablets, USP 5 mg and 10 mg, (USRLD: Compazine). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-03-20 | Glenmark Pharmaceuticals Ltd. India | Glenmark Pharmaceuticals receives ANDA approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg glenmarkpharma.com ↗ |
| 2022-08-11 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Prochlorperazine Maleate Tablets zyduslife.com ↗ |
| 2022-02-22 | Cosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals Launches First Injectable Product – Prochlorperazine Edisylate Injection in the U.S. cosettepharma.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Prochlorperazine | “FOR RESCUE, the subject will be prescribed prochlorperazine 10 mg oral every 4 hours as needed for nausea and prochlorperazine 10 mg intravenous every 4 hours as needed for vomiting.” NCT00711555 ↗30“Anti-emetics (metoclopramide, prochlorperazine and lorazepam) may be prescribed to be used 'as needed' for breakthrough emesis.” NCT01843868 ↗ “Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.” NCT04255420 ↗ “StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache” NCT00422812 ↗ “Prochlorperazine 10 mg administered as an intravenous push over 2 minutes” NCT06904287 ↗ “10 mg Intravenous injection of Prochlorperazine” NCT01785459 ↗ |
| Known as | Buccastem | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Buccastem m | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Compazine | “intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine)” NCT05967442 ↗ |
| Known as | Compro | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | PCZ | “single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.” NCT00610727 ↗ |
| Known as | Prochlorperazine dimaleate | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | prochlorperazine maleate | “Currently, prochlorperazine maleate is approved by the FDA for the treatment of nausea and vomiting, and additionally used off-label as an acute migraine treatment.” NCT06450899 ↗ |
| Known as | Prochlorperazine mesylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Proclorperazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Procomp | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Proziere | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Staccato Prochlorperazine | “Development of Staccato Prochlorperazine for the treatment of migraine headache.” NCT00610428 ↗ |
| Known as | Stemetil eff | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Known as | Vertigon | ChEMBL registry synonym — accepted as the source's own label CHEMBL728 ↗ |
| Action | Inhibit | “prochlorperazine, a dopamine antagonist with known efficacy in migraine” NCT02389829 ↗1“Dopamine D2 receptor antagonist” CHEMBL728 ↗ |
| Modality | Small molecule | — CHEMBL728 ↗ |
| Route | Oral | “10 mg prochlorperazine taken orally every 8 h” PMID 16198982 ↗ Sep 2005 |
| Target | DRD2 | “Dopamine D2 receptor antagonist” CHEMBL728 ↗ |