Drugs / Promethazine
Promethazine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PROMETHAZINE HYDROCHLORIDE PLAIN | — | 1984-04-18 | fda.gov ↗ |
| Approved | US (FDA) | PHENERGAN | — | 1951-03-29 | fda.gov ↗ |
Trials 27 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06663631 | Nov 2024 → Jan 2025 overdue | ischemic stroke | Capital Medical University | Recruiting | No outcome recorded |
| Phase 1 | NCT00947063 | Jul → Aug 2004 | allergic disease | Sandoz | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05922358 | Sep 2023 → Sep 2025 overdue | digestive system neoplasm | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03877718 | Feb → Aug 2019 | migraine disorder | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 2 | NCT02846155 | May → Dec 2016 | stomach disorder | Changhai Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02130622 | Jul 2014 → May 2015 | gastroparesis | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05249933 | Feb 2021 → Feb 2022 | stomach disorder | Changhai Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT01644838 | Aug 2010 → Mar 2011 | — | Mashhad University of Medical Sciences | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT03657810 | Aug 2017 → Apr 2018 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02462850 | Oct 2014 → Jan 2015 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02462811 | Sep 2014 → Jul 2015 | — | Joseph Hazelton | Completed | No outcome recorded |
| Phase 3 | NCT01780428 | Jan → Oct 2013 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01118884 | Jun 2009 → Apr 2010 | — | Shahid Beheshti University | Unknown | No outcome recorded |
| Phase 3 | NCT00455234 | Sep 2005 → Jul 2006 | psychotic disorder | Christian Medical College, Vellore, India | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT04805073 | Aug 2021 → May 2024 | pregnancy disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02136420 | Jun 2014 → Dec 2016 | vestibular disorder | [email protected] | Completed | No outcome recorded |
| Phase 4 | NCT01129934 | May 2010 → Dec 2011 | — | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02635828 | Oct 2009 → May 2011 | — | Ohio State University | Completed | No outcome recorded |
| Phase 4 | NCT00937924 | Feb 2008 → Jun 2012 | — | University of California, Irvine | Completed | No outcome recorded |
| Phase 4 | NCT00270777 | Mar 2005 → Apr 2008 | snakebite envenomation | University of Kelaniya | Completed | No outcome recorded |
| Phase 4 | NCT00429832 | Oct 2003 → Nov 2005 | — | University of New Mexico | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07364344 | Jan → Jul 2026 overdue | ischemic stroke | Ji Xunming,MD,PhD | Not yet recruiting | No outcome recorded |
| — | NCT06874673 | Mar → Sep 2025 overdue | — | Changhai Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06713421 | Dec 2024 → Sep 2025 overdue | esophageal cancer, gastric cancer | Changhai Hospital | Recruiting | No outcome recorded |
| — | NCT02030769 | Jan → Dec 2014 | neoplasm of esophagus | Xijing Hospital of Digestive Diseases | Completed | No outcome recorded |
| — | NCT01159548 | Jul 2010 → Jul 2012 | — | Women's College Hospital | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 21 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06642025 Background | Sep 2024 → Aug 2026 overdue | acute myeloid leukemia | Zhimin Zhai | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT03619954 Background | Jul 2018 → Jul 2019 | — | Anhui Provincial Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT02465866 Comparator | Nov 2014 → Apr 2015 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05852730 Background | Aug 2021 → Sep 2026 expected | space motion sickness | Repurposed Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT02765256 Background | Aug 2016 → Dec 2018 | Crohn disease | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT01953536 Background | Apr 2014 → Nov 2016 | breast neoplasm | Endocyte | Withdrawn | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06561035 Background | Sep 2024 → Aug 2025 overdue | — | Campbell Clinic | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05586763 Comparator | Feb 2022 → Dec 2024 | peripheral vertigo | Oman Medical Speciality Board | Unknown | No outcome recorded |
| Phase 3 | NCT01827293 Comparator | Apr → Jun 2013 | peripheral vertigo | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01814189 Comparator | Jan → Apr 2013 | migraine with aura, migraine without aura | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00861523 Comparator | Feb 2009 → Jan 2012 | hyperemesis gravidarum | HaEmek Medical Center, Israel | Terminated | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03639558 Comparator | Aug 2018 → Jul 2019 | — | Joseph Dib | Completed | No outcome recorded |
| Phase 4 | NCT01846455 Background | Sep 2012 → Apr 2013 | chronic hepatitis C virus infection, liver failure | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01474915 Comparator | Jun 2007 → Dec 2012 | — | Sergio Bergese | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT04237428 Background | May → Jun 2019 | non-Hodgkin lymphoma | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Unknown | No outcome recorded |
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
| — | NCT02473042 Background | Mar 2016 → Nov 2024 | breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT01510379 Background | Aug 2011 → Jul 2012 | — | Kyle A Perry | Completed | No outcome recorded |
| — | NCT01485692 Comparator | Feb 2009 → Mar 2011 | — | University of Sao Paulo | Completed | No outcome recorded |
| — | NCT00655642 Comparator | Mar 2007 → Oct 2008 | — | Vanderbilt University | Terminated | No outcome recorded |
| — | NCT00541671 Comparator | Feb 2007 → Sep 2009 | — | Christiana Care Health Services | Terminated | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Promethazine | “CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg” NCT02462850 ↗38“promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel;” NCT01953536 ↗ “dexamethasone 10mg iv, cimetidine 40mg iv, promethazine 25mg im” NCT05922358 ↗ “Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg” NCT03657810 ↗ “6. Promethazine 25 mg every 8 hours as needed for nausea.” NCT06561035 ↗ “20mg of promethazine intramuscularly or intravenously” NCT06642025 ↗ “promethazine 25mg,i.m.” NCT03619954 ↗ “promethazine 25mg,i.v.” NCT04237428 ↗ |
| Known as | Deyou | “pronase granules（Deyou；Beijing Tide Pharmaceutical Co，China,containing 20,000iu pronase），and clear water before Magnetic-controlled Capsule Endoscopy examination” NCT02846155 ↗ |
| Known as | Phenergan | “Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)” NCT00947063 ↗ |
| Known as | Promethazine HCl | “One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)” NCT03877718 ↗1“Promethazine HCl 50 mg Tablets (Sandoz, Inc)” NCT00947063 ↗ |
| Known as | pronase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05249933 ↗ |
| Action | Inhibit | “H1 antagonist drug” NCT01118884 ↗ |
| Modality | Small molecule | “phenothiazine chemical class” NCT01129934 ↗ |
| Route | Intravenous | “25 mg intravenously” PMID 21572992 ↗ May 2011 |