Chlorpheniramine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | CHLOR-TRIMETON | — | 1982-05-07 – 1986-01-30 | fda.gov ↗ |
| Approved | US (FDA) | CHLOR-TRIMETON | — | 1949-07-13 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05858216 | Jun 2023 → Apr 2024 | voice disorders | Auburn University | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT00932256 | Oct 2009 | seasonal allergic rhinitis | Magna Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00837837 | Dec 2008 → Feb 2009 | allergic disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00853190 | Sep → Oct 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03332524 | Jan 2018 → Sep 2019 | sunburn | Sephoris Pharmaceuticals LLC | Terminated | No outcome recorded |
| Phase 2 | NCT02722083 | May 2016 | allergic rhinitis | Bayer | Terminated | No outcome recorded |
| Phase 2 | NCT02082054 | Mar → May 2014 | seasonal allergic rhinitis | Magna Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05886829 | Jul 2022 → Jan 2023 | COVID-19 | Dr. Ferrer BioPharma | Completed | No outcome recorded |
| Phase 2/3 | NCT05449405 | Dec 2021 → Mar 2022 | COVID-19 | Dr. Ferrer BioPharma | Completed | No outcome recorded |
| Phase 2/3 | NCT04790487 | Jul 2019 → Dec 2020 | allergic rhinitis | Larkin Community Hospital | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01938144 | Apr → Nov 2016 | common cold | Pfizer | Withdrawn | No outcome recorded |
| Phase 3 | NCT01293201 | Mar → Jun 2011 | seasonal allergic rhinitis | Magna Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07536152 | Mar → Nov 2026 expected | — | Kasr El Aini Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03583567 | Sep 2018 → Mar 2019 | hyperheparinemia | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT02246166 | Jan → Feb 2015 | common cold | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04937101 | Jan → Dec 2021 | inflammatory disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT03940391 | May 2019 → Apr 2020 | — | Seoul National University Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02797522 Background | Jun → Nov 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00853294 Comparator | Sep 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04688736 Comparator | Jan 2021 → Dec 2026 expected | — | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT03301454 Background | Aug 2018 → Jul 2022 | esophageal squamous cell carcinoma | Centre Oscar Lambret | Terminated | No outcome recorded |
| Phase 2 | NCT02738008 Background | Mar → Dec 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02604212 Background | Nov 2015 → Dec 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02604199 Background | Sep 2015 → Jan 2017 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02065336 Background | Mar 2014 → Jan 2017 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01902836 Background | Aug 2011 → Dec 2012 | atopic eczema | National Polytechnic Institute, Mexico | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07626437 Comparator | May 2026 → Jun 2027 expected | nasal cavity disorder, viral respiratory tract infection | Brainfarma | Recruiting | No outcome recorded |
| Phase 3 | NCT02735070 Comparator | Sep 2016 → Mar 2017 | — | Brainfarma | Unknown | No outcome recorded |
| Phase 3 | NCT01158326 Comparator | Aug 2010 → Sep 2011 | common cold, influenza | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 3 | NCT00940836 Comparator | Jun → Nov 2009 | common cold | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 3 | NCT01389518 Comparator | May → Jul 2009 | influenza | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 3 | NCT03879772 Background | Mar → Jul 1996 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Chlorpheniramine | “The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine...” NCT01293201 ↗29“1 capsule de active (fixed combination of acetaminophen, chlorpheniramine and phenylephrine) administered in four 4-hour period of wakefulness in between at 07:00 and 23:00...” NCT01389518 ↗ “Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg,...” NCT02246166 ↗ “The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604212 ↗ “usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment” NCT03301454 ↗ “Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side” NCT02082054 ↗ “Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.” NCT00932256 ↗ “Each capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine.” NCT00940836 ↗ “chlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration” NCT07536152 ↗ “IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu” NCT01938144 ↗ “would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604199 ↗ “would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02738008 ↗ “The capsules containing 400mg of paracetamol, 4 mg chlorpheniramine and 4mg phenylephrine.” NCT02735070 ↗ “Paracetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride.” NCT01158326 ↗ “chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks” NCT01902836 ↗ “Antihistamines: diphenhydramine, chlorpheniramine” NCT02033707 ↗ “chlorpheniramine 8 mg PO” NCT02797522 ↗ “Chlorpheniramine (CPM)” NCT04790487 ↗ |
| Known as | BAY X002134 | “Chlorpheniramine maleate (BAY X002134)” NCT02722083 ↗ |
| Known as | CHLOR | “IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu” NCT01938144 ↗ |
| Known as | Chlor-Trimeton | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05858216 ↗ |
| Known as | Chlorpheniramine maleate | “The study intends to determine and compare the safety and synergistic efficacy of the combined dosing of Ibuprofen and Chlorpheniramine maleate vs. each of the individual drugs...” NCT03332524 ↗ |
| Known as | CPM | “Chlorpheniramine (CPM)” NCT04790487 ↗ |
| Action | Inhibit | “reduces the natural chemical histamine in the body” NCT04688736 ↗ |
| Route | Oral | “A single age-/weight-based oral dose, ranging from 1 to 4 mg, was administered with 2 to 6 oz of water at least 2 hours after a light breakfast.” PMID 29136286 ↗ Nov 2017 |