Drugs / Olopatadine

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed seasonal allergic rhinitis 1 milestone
Filed US (FDA) Ryaltris seasonal allergic rhinitis 2018-08-10

“Glenmark announced US FDA’s acceptance of the company’s first New Drug Application (NDA) for Ryaltris™ (olopatadine hydrochloride” glenmarkpharma.com ↗

Approved Indication not stated 5 milestones
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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01326858 Apr → Jun 2011 conjunctivitis Alcon Research Completed No outcome recorded
Phase 24 trials · 1 met primary
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 Met primary
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 · 4 met primary
Phase 3 NCT03463031 Mar → Nov 2018 seasonal allergic rhinitis Glenmark Specialty S.A. Completed Met primary
Phase 3 NCT02870205 Aug 2016 → Jan 2017 seasonal allergic rhinitis Glenmark Specialty S.A. Completed Met primary
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 Met primary
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 Met primary
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 417 trials · 1 met primary
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 NCT01109485 Mar 2010 → Jul 2011 eye allergy Alcon Research Completed No outcome recorded
Phase 4 NCT01119287 Mar → Sep 2010 eye allergy Alcon Research Completed No outcome recorded
Phase 4 NCT01007253 Nov 2009 → Apr 2010 seasonal allergic rhinitis University of Chicago Completed Met primary
Phase 4 NCT00979615 Sep → Nov 2009 vasomotor rhinitis Alcon Research Completed No outcome recorded
Phase not applicable1 trial · 1 met primary
— NCT00609128 Sep 2000 → Nov 2009 conjunctivitis University of Wisconsin, Madison Completed Met primary
Comparator or background therapy26 trials
Phase 1 NCT01495338 Comparator Dec 2011 — Aciex Therapeutics, Inc. Completed No outcome recorded
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

News releases announcing trial results or a regulatory action · 20

DateIssuerRelease
2026-07-21 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark Receives U.S. FDA Approval to Expand the Use of RYALTRIS® Nasal Spray for Children Aged 6 to Less Than 12 Years glenmarkpharma.com ↗
With this approval, RYALTRIS® is now approved in the United States for adults and pediatric patients aged 6 years and older, extending this treatment option to a younger pediatric population.
2025-11-10 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark Secures China Approval For RYALTRIS®, Reinforcing Respiratory Innovation Leadership glenmarkpharma.com ↗
Glenmark Specialty S.A., a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., today announced that the National Medical Products Administration (NMPA) of China has approved RYALTRIS® Compound Nasal Spray (GSP 301 NS) for the treatment of Allergic Rhinitis (AR) in adults and children – specifically for treatment of moderate to severe seasonal AR in adults and pediatric patients 6 years of age and older, and moderate to severe perennial AR in adult s and pediatric patients 12 years of age and older.
2025-03-20 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark receives ANDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC) glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), determined by the FDA to be bioequivalent 1 to Pataday® 2 Once Daily Relief Ophthalmic Solution, 0.2% (OTC), of Alcon Laboratories, Inc.
2024-12-01 Alembic Pharmaceuticals Ltd. Regulatory 4th December, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).
2024-06-27 Lupin Limited Regulatory Lupin Receives Tentative Approval from U.S. FDA for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) lupin.com ↗
2023-03-01 Alcon Research Results Alcon to Debut TOTAL30 for Astigmatism, Dry Eye and Ocular Health Innovations at SECO 2023 alcon.com ↗
The ocular health data focuses on the benefits of Pataday’s dual-action formula and affirms the effectiveness of utilizing two mechanisms of action to provide ocular allergy itch relief: antihistamine and mast cell stabilization.
2022-09-23 Glenmark Pharmaceuticals Ltd. India Regulatory Bausch Health and Glenmark Announce the approval of RYALTRIS® in Canada glenmarkpharma.com ↗
RYALTRIS ® (olopatadine hydrochloride and mometasone furoate nasal sp ray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.
2021-09-30 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark receives marketing approval for Ryaltris®, an innovative combination nasal spray, in 13 countries across the EU and UK glenmarkpharma.com ↗
2021-04-26 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark’s Ryaltris ® nasal spray now approved in Europe for the first line treatment of allergic rhinitis in patients over 12 years of age glenmarkpharma.com ↗
Glenmark’s Ryaltris ® nasal spray now approved in Europe for the first line treatment of allergic rhinitis in patients over 12 years of age
2021-02-22 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark’s Ryaltris®- innovative single nasal spray, ready to market in Russia glenmarkpharma.com ↗
Marketing approval received from the Ministry of Health of the Russian Federation
2020-07-14 Alcon Research Regulatory Alcon Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength alcon.com ↗
2020-02-17 Alcon Research Regulatory Alcon to Launch Pataday, the Eye Allergy Drop with the #1 Doctor-Prescribed Active Ingredient, following FDA Approval of OTC Switch alcon.com ↗
today announced that Pataday® Once Daily Relief and Pataday® Twice Daily Relief have been approved by the Food and Drug Administration (FDA) for sale over the counter (OTC) in the U.S.

All press releases naming this drug 26 releases

DateIssuerRelease

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 65 sources stand behind the page.

FieldValueCited 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 2019
55

“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 ↗

NCT02322216 ↗

NCT00987272 ↗

NCT00772304 ↗

NCT01282138 ↗

Show 45 more sources

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 ↗
3

NCT01479374 ↗

NCT01294969 ↗

NCT01698814 ↗

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 ↗

Show 15 more sources

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 ↗

NCT03320434 ↗

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 ↗