Olopatadine
Other / unclassified targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PATADAY ONCE DAILY RELIEF | — | 2020-07-13 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | PATADAY TWICE DAILY RELIEF | — | 2000-03-20 – 2020-02-14 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | PATANASE | — | 2009-06-17 – 2010-03-31 | fda.gov ↗ |
| Approved | EU (EMA) | Opatanol | — | 2002-05-16 | europa.eu ↗ |
| Approved | US (FDA) | PATADAY TWICE DAILY RELIEF | — | 1996-12-18 | fda.gov ↗ |
Trials 36 · a red edge is where a trial was stopped
| 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 24 trials | ||||||
| Phase 2 | NCT06126952 | Oct 2023 → Feb 2024 | seasonal allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 2 | NCT03444506 | Jan → Feb 2014 | seasonal allergic rhinitis | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 2 | NCT01287338 | Oct 2010 → Jan 2011 | conjunctivitis | Mati Therapeutics Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00794144 | Oct → Dec 2008 | allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT03463031 | Mar → Nov 2018 | seasonal allergic rhinitis | Glenmark Specialty S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02870205 | Aug 2016 → Jan 2017 | seasonal allergic rhinitis | Glenmark Specialty S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02709538 | Apr 2016 → Jul 2017 | perennial allergic rhinitis | Glenmark Specialty S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02631551 | Mar → Jul 2016 | seasonal allergic rhinitis | Glenmark Specialty S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02322216 | Dec 2014 → Oct 2015 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT02161146 | Jun → Dec 2014 | conjunctivitis | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01743027 | Jan → Jul 2013 | eye allergy | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01698814 | Oct 2012 → Jan 2013 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01037179 | Feb → May 2010 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00987272 | Oct → Nov 2009 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00578929 | Sep 2007 → Nov 2008 | seasonal allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00578331 | Dec 2006 → Jan 2008 | perennial allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00331500 | Apr → Jul 2006 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT02251613 | Dec 2013 → Jan 2014 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01697969 | Sep 2012 → Jul 2013 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01272089 | May → Dec 2011 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01282138 | Dec 2010 → Mar 2011 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01294969 | Sep 2010 → Oct 2011 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01159769 | Jun → Aug 2010 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01119287 | Mar → Sep 2010 | eye allergy | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01109485 | Mar 2010 → Jul 2011 | eye allergy | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01007253 | Nov 2009 → Apr 2010 | seasonal allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00979615 | Sep → Nov 2009 | vasomotor rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00845195 | Mar → May 2009 | seasonal allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00789555 | Nov 2008 → Jan 2011 | perennial allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00772304 | Oct → Nov 2008 | allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00818805 | Jul 2008 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00691665 | May 2008 → Jan 2009 | seasonal allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00489398 | Jul 2007 → Dec 2008 | conjunctivitis | Hom, Milton M., OD, FAAO | Withdrawn | No outcome recorded |
| Phase 4 | NCT00389025 | Oct 2006 → Apr 2007 | eye allergy | Alcon Research | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00609128 | Sep 2000 → Nov 2009 | conjunctivitis | University of Wisconsin, Madison | Completed | No outcome recorded |
Also used as a comparator or background therapy in 26 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01495338 Comparator | Dec 2011 | — | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03320434 Comparator | Oct 2017 → Feb 2018 | conjunctivitis | ORA, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02318303 Comparator | Dec 2014 → Feb 2015 | seasonal allergic rhinitis | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 2 | NCT01344083 Comparator | Apr 2011 → Feb 2012 | conjunctivitis | Laboratoires Thea | Completed | No outcome recorded |
| Phase 2 | NCT00836485 Comparator | Feb → Mar 2009 | conjunctivitis | Senju USA, Inc. | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT02478398 Background | Jul 2015 → Nov 2018 | seasonal allergic rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01657240 Comparator | Nov 2014 → Apr 2015 | conjunctivitis | Laboratorios Sophia S.A de C.V. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01700192 Background | Jan 2013 → Apr 2015 | perennial allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT01479374 Comparator | Jan → Mar 2012 | conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01258309 Comparator | Dec 2010 → Jan 2011 | conjunctivitis, seasonal allergic rhinitis | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01435460 Comparator | Aug 2010 → Apr 2011 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00550550 Background | Nov 2007 → Sep 2009 | allergic rhinitis, conjunctivitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT00562159 Background | Nov 2007 → Sep 2009 | allergic disease, conjunctivitis, rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT01363700 Comparator | ? → Jun 2012 | conjunctivitis | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT05314621 Comparator | Dec 2021 → Jul 2022 | conjunctivitis | Andover Research Eye Institute | Completed | No outcome recorded |
| Phase 4 | NCT05265910 Comparator | Dec 2021 → Apr 2022 | conjunctivitis | Andover Research Eye Institute | Completed | No outcome recorded |
| Phase 4 | NCT04708821 Comparator | Apr → Sep 2021 | conjunctivitis | Clinical Research Center of Florida | Completed | No outcome recorded |
| Phase 4 | NCT04776096 Comparator | Mar 2021 → Aug 2022 | eye allergy | Laboratorios Poen | Completed | No outcome recorded |
| Phase 4 | NCT03186755 Comparator | Jun 2017 → Dec 2024 | vernal conjunctivitis | Michael Marchand, MD | Unknown | No outcome recorded |
| Phase 4 | NCT01732757 Comparator | Nov → Dec 2012 | atopic conjunctivitis | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01470118 Comparator | Oct → Dec 2011 | atopic conjunctivitis | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00655109 Comparator | Feb → Mar 2008 | conjunctivitis | Greiner, Jack V., OD DO PhD | Completed | No outcome recorded |
| Phase 4 | NCT00534794 Comparator | Oct 2007 → Jan 2008 | conjunctivitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT01076439 Comparator | — | allergic rhinitis | ORA, Inc. | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01450176 Comparator | Sep → Oct 2011 | eye allergy | McCabe Vision Center | Completed | No outcome recorded |
| — | NCT00775658 Comparator | Jan → Jun 2008 | allergic rhinitis, conjunctivitis | Vanderbilt University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-06 | Alcon Research | Football Star Cooper Kupp Encourages Eye Allergy Sufferers to Find the Right Tool for the Job with Pataday alcon.com ↗ |
| 2021-02-18 | Alcon Research | Alcon Announces Broad Retail Availability of Pataday Once Daily Relief Extra Strength in the U.S. alcon.com ↗ |
| 2020-07-14 | Alcon Research | Alcon Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength alcon.com ↗ |
| 2020-02-17 | Alcon Research | Alcon to Launch Pataday, the Eye Allergy Drop with the #1 Doctor-Prescribed Active Ingredient, following FDA Approval of OTC Switch alcon.com ↗ |
| 2017-06-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Exclusive Launch of Generic Pataday® in the United States tevapharm.com ↗ |
| 2015-02-02 | Novartis Pharmaceuticals | Alcon receives FDA approval of Pazeo(TM) Solution for ocular allergy itch relief novartis.com ↗ |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | olopatadine | “In this double-blind study, eligible patients (≥12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 μg of olopatadine and 25 μg of mometasone),...” PMID 30910440 ↗ Mar 201955“Background: Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, was established in three...” PMID 31248471 ↗ Jun 2019 “Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using...” PMID 26266427 ↗ Oct 2015 “Olopatadine hydrochloride 0.1% ophthalmic solution was administered intraocularly at a dose of 1 drop in each affected eye twice daily as rescue medication for...” NCT00562159 ↗ “GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate.” PMID 35926824 ↗ Aug 2022 “665 μg of olopatadine twice-daily” PMID 30321655 ↗ Oct 2018 “Olopatadine HCl NS” NCT02631551 ↗ |
| Known as | AL-4943A | “The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.” NCT01037179 ↗ |
| Known as | Allelock | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | ALO-4943A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | KW-4679 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | OLO | “olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO)” NCT01007253 ↗ |
| Known as | Olopatadina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | Olopatadine (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | Olopatadine HCL | “Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily” NCT00691665 ↗4“Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril” NCT02318303 ↗ “Olopatadine HCl 1 or 2 sprays per nostril twice daily” NCT00578929 ↗ “Olopatadine HCL (Patanase) Nasal Spray, 0.6%” NCT00979615 ↗ “Olopatadine HCl ophthalmic solution, 0.1%” NCT02251613 ↗ |
| Known as | Olopatadine hydrochloride | “Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight...” NCT00609128 ↗25“A Randomized, Double-Masked, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of Maxidex® (0.1% Dexamethasone) Ophthalmic Suspension and Patanol® (0.1%...” NCT01119287 ↗ “Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication...” NCT00550550 ↗ “Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and saline nasal spray will be administered...” NCT05314621 ↗ “Background: Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, was established in three...” PMID 31248471 ↗ Jun 2019 “PURPOSE: To assess the efficacy and safety of a novel once-daily 0.77% olopatadine hydrochloride ophthalmic solution in subjects with allergic conjunctivitis (AC) using the...” PMID 26266427 ↗ Oct 2015 “GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis...” PMID 30321655 ↗ Oct 2018 “The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.” NCT01037179 ↗ “GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate.” PMID 35926824 ↗ Aug 2022 “GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).” PMID 30910440 ↗ Mar 2019 “Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally” NCT05265910 ↗ “Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray” NCT06126952 ↗ “PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration.” NCT04708821 ↗ “Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.” NCT01700192 ↗ “Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine)” NCT03186755 ↗ “Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)” NCT01159769 ↗ “Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)” NCT01282138 ↗ “Olopatadine Hydrochloride Ophthalmic Solution, 0.2%” NCT00987272 ↗ “Olopatadine hydrochloride ophthalmic solution, 0.2%” NCT01479374 ↗ “Olopatadine hydrochloride ophthalmic solution, 0.2%” NCT01697969 ↗ “olopatadine hydrochloride 0.1% ophthalmic solution” NCT01258309 ↗ “Olopatadine hydrochloride ophthalmic solution 0.1%” NCT01109485 ↗ “Olopatadine Hydrochloride Nasal Spray 0.6%” NCT00578929 ↗ “olopatadine hydrochloride (antihistamine)” PMID 31734334 ↗ Nov 2019 |
| Known as | olopatadine hydrochloride (HCl) | “the antihistamine, olopatadine hydrochloride (HCl)” PMID 31053180 ↗ May 2019 |
| Known as | Olopatadine hydrochloride component of ryaltris | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | Opatanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | Pataday | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00534794 ↗ |
| Known as | Pataday once daily relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | Pataday Once Daily Relief Extra Strength | “Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and saline nasal spray will be administered...” NCT05314621 ↗ |
| Known as | Pataday twice daily relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Known as | Patanase | “Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%)” NCT00794144 ↗2“Olopatadine HCL (Patanase) Nasal Spray, 0.6%” NCT00979615 ↗ “Olopatadine Nasal Spray (Patanase)” NCT01076439 ↗ |
| Known as | PATANOL | “Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight...” NCT00609128 ↗2“A Randomized, Double-Masked, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of Maxidex® (0.1% Dexamethasone) Ophthalmic Suspension and Patanol® (0.1%...” NCT01119287 ↗ |
| Known as | Pazeo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189432 ↗ |
| Action | Inhibit | “a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells” NCT03186755 ↗1“Histamine H1 receptor antagonist” CHEMBL1189432 ↗ |
| Modality | Other / unclassified | “an antihistamine drop in the eye” NCT01007253 ↗ |
| Route | Other | “dosed intraocularly” NCT00550550 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL1189432 ↗ |