Drugs / Ketotifen
Ketotifen
also known as
Ketotifen fumarate · (r)-ketotifen · Acuvue theravision with ketotifen · Alaway · Children's alaway · HC 20,511 FUMARATE · Ketotifen (as fumarate) · Ketotifen hydrogen fumarate · +6 more
Small molecule targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ZADITOR | — | 2006-10-19 | fda.gov ↗ |
| Approved | US (FDA) | ZADITOR | — | 1999-07-02 | fda.gov ↗ |
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01326858 | Apr → Jun 2011 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 28 trials · 1 missed | ||||||
| Phase 2 | NCT07526558 | Apr 2026 → Jan 2027 expected | tick-borne infectious disease | University of North Carolina, Chapel Hill | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07257029 | Jan → Aug 2026 overdue | mast cell activation syndrome, vaginal disorder, vulvodynia | Center for Vulvovaginal Disorders | Recruiting | No outcome recorded |
| Phase 2 | NCT06942390 | Jun 2025 → Jun 2026 overdue | hyperpigmentation of the skin | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03388138 | Dec 2017 → Feb 2018 | — | Johnson & Johnson Vision Care, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01902017 | Jun 2013 → Aug 2017 | — | University of Calgary | Completed | Missed primary |
| Phase 2 | NCT01625715 | Jan 2011 → Jun 2012 | — | Gordon Sussman Clinical Research | Unknown | No outcome recorded |
| Phase 2 | NCT00836485 | Feb → Mar 2009 | conjunctivitis | Senju USA, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00375596 | — | conjunctivitis | Bausch & Lomb Incorporated | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 311 trials | ||||||
| Phase 3 | NCT05815758 | Apr → Sep 2023 | eye allergy | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT05591755 | Nov 2022 → Aug 2023 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT05579730 | Oct 2022 → Jul 2023 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT05007522 | May 2022 → Jun 2024 | COVID-19 | Sen-Jam Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT03489941 | Apr 2018 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT02984397 | Dec 2016 → Jan 2020 | chronic pain syndrome | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| Phase 3 | NCT00770133 | Feb → Apr 2010 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00769886 | Oct → Dec 2008 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00445874 | Feb → May 2007 | conjunctivitis | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00432757 | Jan → Mar 2007 | conjunctivitis | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00639587 | Aug 2002 → Mar 2003 | perennial allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT05616442 | May 2023 → Mar 2025 | liver disorder | Tanta University | Completed | Met primary |
| Phase 4 | NCT05511831 | Sep 2022 → Dec 2023 | ST-elevation myocardial infarction | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02673840 | Mar 2015 → Jul 2016 | dengue disease | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 4 | NCT00133627 | Apr → Oct 2005 | conjunctivitis | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00446056 | Sep 2003 → Jun 2004 | asthma | Organon and Co | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04399148 | Jun → Sep 2019 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 3 | NCT05624138 Comparator | Nov 2022 → Apr 2024 overdue | peripheral neuropathy | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT03582176 Comparator | Apr 2019 → Sep 2024 | — | University of Calgary | Completed | No outcome recorded |
| Phase 3 | NCT03479307 Comparator | Apr → Aug 2018 | eye allergy | Faes Farma, S.A. | Completed | Met primary |
| Phase 3 | NCT02484248 Comparator | Aug 2015 → Apr 2027 expected | dyspepsia | Craig A. Friesen, MD | Recruiting | No outcome recorded |
| Phase 3 | NCT01840605 Comparator | Mar → Nov 2013 | atopic eczema | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01553318 Comparator | Mar → Dec 2012 | fibromyalgia | Indiana University | Completed | No outcome recorded |
| Phase 3 | NCT00426023 Comparator | Feb 2007 → Oct 2008 | vernal keratoconjunctivitis | Campus-Bio-Medico University | Completed | No outcome recorded |
| Phase 3 | NCT02182557 Comparator | Jun 2001 → Jan 2002 | atopic eczema | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02182544 Comparator | Jun → Dec 2001 | perennial allergic rhinitis | Boehringer Ingelheim | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-03-26 | Janssen Research & Development, LLC | Results Johnson & Johnson Vision’s Investigational Antihistamine-Releasing Contact Lens Demonstrates Positive Phase 3 Results jnj.com ↗
Johnson & Johnson Vision today announced that results from two Phase 3 clinical studies evaluating the company’s investigational antihistamine-releasing contact lens (etafilcon A with 0.019 mg ketotifen) were published in the journal Cornea. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-26 | Janssen Research & Development, LLC | Johnson & Johnson Vision’s Investigational Antihistamine-Releasing Contact Lens Demonstrates Positive Phase 3 Results jnj.com ↗ |
| 2010-03-15 | Perrigo Company | Perrigo Announces Launch of Generic Version of Zaditor™ perrigo.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 | Ketotifen | “This arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing...” NCT06942390 ↗ |
| Known as | (r)-ketotifen | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Acuvue theravision with ketotifen | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Alaway | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Children's alaway | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | HC 20,511 FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Ketotifen (as fumarate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Ketotifen fumarate | “Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%)” NCT03489941 ↗ |
| Known as | Ketotifen hydrogen fumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Ketotifen Oral Tablet | “Drug: Ketotifen Oral Tablet” NCT05624138 ↗ |
| Known as | Ketotifene | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Ketotifeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | NSC-757415 | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Zaditen | ChEMBL registry synonym — accepted as the source's own label CHEMBL534 ↗ |
| Known as | Zaditor | “A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle” NCT03489941 ↗ |
| Action | Inhibit | “Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation.” NCT01553318 ↗1“Histamine H1 receptor antagonist” CHEMBL534 ↗ |
| Modality | Small molecule | — CHEMBL534 ↗ |
| Route | Topical | “eye drop formulation” NCT00133627 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL534 ↗ |