Drugs / Epinastine
Epinastine
also known as
Epinastine Hydrochloride · WAL 801 CL · Alesion · DE-114 · Elestat · ELESTAT (epinastine HCl ophthalmic solution) 0.05% · Epinastina · Epinastine HCl · +5 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 |
|---|---|---|---|---|---|
| Filed atopic conjunctivitis 1 milestone | |||||
| Filed | Japan (PMDA) | — | atopic conjunctivitis | 2023-03-27 | “announced today that it has filed an application for manufacturing and marketing approval of STN1011402 (generic name: epinastine hydrochloride) ophthalmic cream in Japan.” santen.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ELESTAT | — | 2003-10-16 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02260037 | Aug → Sep 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182531 | Aug → Oct 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02260063 | Nov 1998 → Jan 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00407927 | Dec 2006 → Mar 2007 | seasonal allergic rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01382654 | Sep → Oct 2006 | allergic rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT06212973 | Mar → Nov 2023 | conjunctivitis | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00564421 | Dec 2007 → Feb 2008 | seasonal allergic rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02182544 | Jun → Dec 2001 | perennial allergic rhinitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02182570 | Jun 2001 → Feb 2002 | atopic eczema | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02182557 | Jun 2001 → Jan 2002 | atopic eczema | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02182518 | May 2000 → Jul 2001 | perennial allergic rhinitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01363700 | ? → Jun 2012 | conjunctivitis | Santen Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT01363713 | ? → Sep 2012 | conjunctivitis | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT00534794 | Oct 2007 → Jan 2008 | conjunctivitis | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 4 | NCT00489398 | Jul 2007 → Dec 2008 | conjunctivitis | Hom, Milton M., OD, FAAO | Withdrawn | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT02251613 Comparator | Dec 2013 → Jan 2014 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01569191 Comparator | Mar → Nov 2012 | hypersensitivity reaction disease | Aston University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-03-26 | Santen Gmbh | Regulatory Santen obtains manufacturing and marketing approval in Japan for Alesion® eyelid cream (epinastine hydrochloride), a new treatment for allergic conjunctivitis santen.com ↗ |
| 2023-03-27 | Santen Gmbh | Regulatory Santen Files for Manufacturing and Marketing Approval for STN1011402 (Epinastine Hydrochloride) Ophthalmic Cream in Japan - Applied once daily to periocular area, new formulation for treatment of allergic conjunctivitis- santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application for manufacturing and marketing approval of STN1011402 (generic name: epinastine hydrochloride) ophthalmic cream in Japan. |
| 2011-11-01 | Perrigo Company | Regulatory Perrigo Announces Launch of Generic Version of Elestat® perrigo.com ↗
Perrigo Company (Nasdaq: PRGO;TASE) today announced that its partner, PharmaForce/Luitpold Pharmaceuticals, received final approval for Epinastine HCl ophthalmic solution, 0.05%, a generic version of Elestat®. |
All press releases naming this drug 8 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | epinastine | “The anti-allergic drug epinastine hydrochloride (Elestat, Allergan) is a prescription only medicine indicated for the treatment of allergic conjunctivitis.” NCT01569191 ↗11“Epinastine hydrochloride is a selective histamine H1 receptor antagonist that also inhibits IgE receptor-mediated histamine release from mast cells.” PMID 25163405 ↗ Aug 2014 |
| Known as | Alesion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1106 ↗ |
| Known as | DE-114 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01363713 ↗ |
| Known as | Elestat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00534794 ↗ |
| Known as | ELESTAT (epinastine HCl ophthalmic solution) 0.05% | “ELESTAT® (epinastine HCl ophthalmic solution) 0.05%” NCT01569191 ↗ |
| Known as | Epinastina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1106 ↗ |
| Known as | Epinastine HCl | “Epinastine HCl ophthalmic solution, 0.05%” NCT02251613 ↗ |
| Known as | Epinastine Hydrochloride | “The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.” NCT02182570 ↗3“The anti-allergic drug epinastine hydrochloride (Elestat, Allergan) is a prescription only medicine indicated for the treatment of allergic conjunctivitis.” NCT01569191 ↗ “Epinastine hydrochloride is a selective histamine H1 receptor antagonist that also inhibits IgE receptor-mediated histamine release from mast cells.” PMID 25163405 ↗ Aug 2014 “WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis” NCT02182544 ↗ |
| Known as | Flurinol | “To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets” NCT02260063 ↗ |
| Known as | Purivist | ChEMBL registry synonym — accepted as the source's own label CHEMBL1106 ↗ |
| Known as | Relestat | ChEMBL registry synonym — accepted as the source's own label CHEMBL1106 ↗ |
| Known as | WAL 801 CL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02182557 ↗ |
| Known as | WAL-802-CL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1106 ↗ |
| Known as | WAL801 | “Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry...” NCT02182557 ↗ |
| Action | Inhibit | “Epinastine hydrochloride is a selective histamine H1 receptor antagonist” PMID 25163405 ↗ Aug 20141“Histamine H1 receptor antagonist” CHEMBL1106 ↗ |
| Modality | Small molecule | — CHEMBL1106 ↗ |
| Route | Intranasal | “Epinastine Nasal Spray” NCT00407927 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL1106 ↗ |