Drugs / Bepotastine
Bepotastine
also known as
bepotastine besilate · Bepreve · BBOS · TALION tab · TAU-284 · Bepotastina · Bepotastine benzenesulfonate salt · bepotastine besylate · +5 more
Small molecule targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BEPREVE | — | 2009-09-08 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 met primary | ||||||
| Phase 1 | NCT04693429 | Sep → Nov 2020 | — | Laboratorios Sophia S.A de C.V. | Completed | No outcome recorded |
| Phase 1 | NCT04097951 | Nov 2019 → Jan 2020 | respiratory system disorder | Hyundai Pharmaceutical Co., LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT03200496 | May → Jun 2017 | — | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02686294 | Feb → Mar 2016 | perennial allergic rhinitis | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02682745 | Jan → Feb 2016 | perennial allergic rhinitis | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02332044 | Apr → Sep 2014 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT01897428 | Apr → May 2011 | allergic rhinitis, urticaria | Korea University Anam Hospital | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01222299 | May → Aug 2010 | seasonal allergic rhinitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01753739 | Jan → Feb 2013 | seasonal allergic rhinitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01578278 | Dec 2011 → Aug 2012 | seasonal allergic rhinitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01277341 | Dec 2010 → Feb 2011 | seasonal allergic rhinitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01174823 | Jun → Oct 2010 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00424398 | Feb → Jul 2007 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT01900054 | Jun → Nov 2013 | perennial allergic rhinitis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01861522 | Apr → Dec 2013 | perennial allergic rhinitis | Tanabe Pharma Corporation | Completed | Met primary |
| Phase 3 | NCT01840605 | Mar → Nov 2013 | atopic eczema | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01425632 | Aug → Dec 2011 | perennial allergic rhinitis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00586664 | Oct 2007 → Jun 2008 | conjunctivitis | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT00586625 | Oct 2007 → May 2008 | eye allergy | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04776096 | Mar 2021 → Aug 2022 | eye allergy | Laboratorios Poen | Completed | No outcome recorded |
| Phase 4 | NCT01337557 | May → Sep 2011 | conjunctivitis | Hom, Milton M., OD, FAAO | Unknown | No outcome recorded |
| Phase 4 | NCT01128556 | Apr → Jun 2010 | allergic disease | North Texas Institute for Clinical Trials | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT01925313 Comparator | Dec 2012 → Feb 2013 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 4 | NCT04877678 Comparator | Oct 2021 → Sep 2022 | allergic rhinitis | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01443442 Comparator | Oct 2011 → Sep 2012 | conjunctivitis | Southern California College of Optometry at Marshall B. Ketchum University | Completed | No outcome recorded |
| Phase 4 | NCT01346371 Comparator | May 2011 → Aug 2012 | conjunctivitis | Minnesota Eye Consultants, P.A. | Completed | No outcome recorded |
| — | NCT01450176 Comparator | Sep → Oct 2011 | eye allergy | McCabe Vision Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf alembicpharmaceuticals.com ↗ |
| 2018-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals by the Ministry of Health, Labour and Welfare for eight molecules in 19 presentations of generic drugs. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-07-01 | Alembic Pharmaceuticals Ltd. | APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf alembicpharmaceuticals.com ↗ |
| 2018-02-15 | Upsher-Smith Laboratories | Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗ |
| 2011-05-27 | Tanabe Pharma Corporation | Launch of Anti-allergy Agent, Bepotastine Besilate in China and Indonesia tanabe-pharma.com ↗ |
| 2011-01-03 | Dong-A ST Co., Ltd. | Dong-A Signs License Agreement to Exclusively Develop and Market TALION Eye Drops, an Allergic Conjunctivitis Treatment, in Korea donga-st.com ↗ |
| 2010-12-21 | Tanabe Pharma Corporation | Out-Licensing of Bepotastine Besilate for Ophthalmic Use to a South Korea tanabe-pharma.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bepotastine | “The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as...” NCT02686294 ↗12“The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as...” NCT02682745 ↗ “Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers” NCT00586625 ↗ “Montelukast and Bepotastine Combination” NCT04097951 ↗ “Bepotastine besilate 10mg” NCT02332044 ↗ |
| Known as | BBOS | “This report examines the reduction of ocular itching integrated from two conjunctival allergen challenge (CAC) clinical trials comparing bepotastine besilate ophthalmic...” PMID 22991696 ↗ May 20121“Bepotastine besilate ophthalmic solution (BBOS) 1.5%, a dual-acting histamine (H(1)) receptor antagonist and mast cell stabilizer, is indicated for itching associated with AC.” PMID 23484763 ↗ May 2013 |
| Known as | Bepotastina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201758 ↗ |
| Known as | Bepotastine benzenesulfonate salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201758 ↗ |
| Known as | bepotastine besilate | “The aim of the present study was to compare the pharmacokinetics of two different bepotastine formulations [bepotastine besilate 10 mg (reference) and bepotastine salicylate...” PMID 24105252 ↗ Dec 201313“Bepotastine besilate ophthalmic solution (BBOS) 1.5%, a dual-acting histamine (H(1)) receptor antagonist and mast cell stabilizer, is indicated for itching associated with AC.” PMID 23484763 ↗ May 2013 “The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer” NCT01346371 ↗ “Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses” NCT01337557 ↗ “DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate” NCT03200496 ↗ “Bepotastine Besilate Ophthalmic Solution 1.5%” NCT00424398 ↗ |
| Known as | bepotastine besylate | “To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.” NCT01925313 ↗ |
| Known as | bepotastine salicylate | “The aim of the present study was to compare the pharmacokinetics of two different bepotastine formulations [bepotastine besilate 10 mg (reference) and bepotastine salicylate...” PMID 24105252 ↗ Dec 2013 |
| Known as | Bepreve | “Bepotastine Besilate Ophthalmic Solution 1.5% (Bepreve) Study Group.” PMID 23484763 ↗ May 2013 |
| Known as | Betotastine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201758 ↗ |
| Known as | DA-5206 | “DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate” NCT03200496 ↗ |
| Known as | HL151 | “The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as...” NCT02686294 ↗ |
| Known as | Talion | “DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate” NCT03200496 ↗ |
| Known as | TALION tab | “The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as...” NCT02686294 ↗1“The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as...” NCT02682745 ↗ |
| Known as | TAU-284 | “The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12...” NCT01900054 ↗ |
| Action | Inhibit | “Bepotastine besilate is a selective H(1)-antagonist with mast cell stabilizing properties.” PMID 22991696 ↗ May 20121“Histamine H1 receptor antagonist” CHEMBL1201758 ↗ |
| Modality | Small molecule | — CHEMBL1201758 ↗ |
| Route | Topical | “One drop, both eyes, twice a day” NCT00586625 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL1201758 ↗ |