Drugs / Lifitegrast
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn dry eye syndrome 4 milestones | |||||
| Withdrawn | EU (EMA) | Xiidra | dry eye syndrome | 2020-06-26 | “Xiidra EU Filing has been withdrawn following objections raised by the CHMP during the application process” novartis.com ↗ |
| Filed | US (FDA) | — | dry eye syndrome | 2016-01-25 | “today announced it has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational candidate, lifitegrast” takeda.com ↗ |
| Rejected (CRL) | US (FDA) | — | dry eye syndrome | 2015-10-16 | “On October 16, 2015, the US Food and Drug Administration (“FDA”) issued a complete response letter requesting an additional clinical study to support the new drug application...” takeda.com ↗ |
| Filed | US (FDA) | — | dry eye syndrome | 2015-04-09 | “today announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast” takeda.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | XIIDRA | — | 2016-07-11 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04792580 | Oct 2022 → Apr 2024 | graft versus host disease | Richard W Yee, MD | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT07040826 | Dec 2022 | dry eye syndrome | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00936520 | Aug 2009 → May 2010 | diabetic macular edema | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT00926185 | Aug 2009 → Feb 2010 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00882687 | Apr → May 2009 | eye allergy | Shire | Completed | Missed primary |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT07111013 | Dec 2025 → Apr 2027 | dry eye syndrome | Bausch & Lomb Incorporated | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06879782 | Mar 2024 → Mar 2026 overdue | dry eye syndrome | Lunan Better Pharmaceutical Co., LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT02284516 | Nov 2014 → Oct 2015 | dry eye syndrome | Shire | Completed | Met primary |
| Phase 3 | NCT01743729 | Dec 2012 → Oct 2013 | dry eye syndrome | Shire | Completed | Mixed |
| Phase 3 | NCT01636206 | Oct 2012 → Mar 2014 | dry eye syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01421498 | Aug 2011 → Apr 2012 | dry eye syndrome | Shire | Completed | Mixed |
| Phase 411 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07560735 | Apr → Sep 2026 overdue | dry eye syndrome | Toyos Clinic | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07490535 | Mar → Sep 2026 overdue | dry eye syndrome | Pittsburgh Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07025811 | Jul 2025 → Jul 2026 overdue | dry eye syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05505292 | Sep 2022 → May 2023 | dry eye syndrome | State University of New York College of Optometry | Completed | Missed primary |
| Phase 4 | NCT04297618 | Jul 2021 → Apr 2024 | dry eye syndrome | University of Waterloo | Completed | Met primary |
| Phase 4 | NCT04669561 | Mar → Aug 2021 | dry eye syndrome | Research Insight LLC | Completed | No outcome recorded |
| Phase 4 | NCT03952481 | Mar → Dec 2021 | dry eye syndrome | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 4 | NCT05045053 | Feb 2021 → Jan 2022 | corneal disorder | Benha University | Unknown | No outcome recorded |
| Phase 4 | NCT03408015 | Jan 2019 | asthenopia, dry eye syndrome | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 4 | NCT03431272 | Nov → Dec 2018 | dry eye syndrome | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 4 | NCT03686878 | Dec 2016 → Jul 2017 | dry eye syndrome | EV Clinical Trials | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1/2 | NCT04030962 Comparator | Mar 2020 → Mar 2022 | dry eye syndrome | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT07128628 Comparator | Oct 2025 → May 2026 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT05102409 Comparator | Sep → Oct 2021 | dry eye syndrome | Aldeyra Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04734197 Comparator | Jan 2021 → Mar 2022 | dry eye syndrome | Surface Ophthalmics, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04120987 Comparator | May 2021 → Jun 2022 | dry eye syndrome | Bucci Laser Vision Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT05594745 Comparator | Mar 2021 → Jan 2023 | dry eye syndrome | Tauber Eye Center | Completed | No outcome recorded |
| Phase 4 | NCT04413253 Comparator | Aug 2020 → Apr 2022 | dry eye syndrome | Eye Surgeons of Indiana | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04172961 Comparator | Feb 2020 → Dec 2022 | dry eye syndrome | Toyos Clinic | Unknown | No outcome recorded |
| Phase 4 | NCT03451396 Comparator | Dec 2016 → Feb 2018 | dry eye syndrome | Lifelong Vision Foundation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Bausch Health Americas, Inc. | Results Bausch + Lomb Advancing Two First-in-Class Eye Health Therapies Based on Trial Results bausch.com ↗
Dry Eye Disease Dual-Action Eye Drop: Phase 2 Results Support Advancement to Phase 3 with Day 15 Primary Endpoint |
| 2022-01-11 | Aldeyra Therapeutics, Inc. | Results Aldeyra Therapeutics Announces Positive Top-Line Data from Phase 2 Dry Eye Chamber Clinical Trial of Reproxalap, an Investigational New Drug, Compared to Xiidra® aldeyra.com ↗
Patient-reported ocular discomfort (p=0.002) and itching (p=0.01) were statistically lower with reproxalap than with Xiidra. |
| 2020-06-29 | Takeda | Regulatory Takeda Announces Anticipated Financial Impact from Novartis’ Withdrawal of the Marketing Authorisation Application for Xiidra ® takeda.com ↗ |
| 2020-02-24 | Aldeyra Therapeutics, Inc. | Results Aldeyra Therapeutics to Provide Update on Late-Stage Clinical Development Pipeline at 2020 Research & Development Day aldeyra.com ↗
The tolerability of both formulations of reproxalap, as assessed by a variety of drop experience scores including ocular discomfort, blurry vision, and taste disturbance, was statistically superior to that of Xiidra®. |
| 2018-05-02 | RegeneRx Biopharmaceuticals, Inc. | Results ReGenTree Presents Results of a Comparison Study of RGN-259 and Approved Prescription Drugs for Dry Eye Syndrome in a Mouse Model at ARVO regenerx.com ↗
Such improvements with RGN-259 treatment were comparable to or better than that seen with approved prescription treatments such as cyclosporine A (Restasis®), lifitegrast (Xiidra®), and diquafosol (Diquas®), which are marketed in the USA or Japan. |
| 2018-01-03 | Takeda | Regulatory Xiidra®* (Lifitegrast Ophthalmic Solution 5%) Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease takeda.com ↗
Canada approval represents Shire’s first international market authorization for Xiidra outside of the United States. |
| 2017-08-15 | Takeda | Regulatory Shire announces submission of lifitegrast Marketing Authorization Application for treatment of dry eye disease in Europe takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure (DCP). |
| 2016-07-11 | Takeda | Regulatory FDA Approves Shire’s Xiidra™ (lifitegrast ophthalmic solution) 5% – The Only Treatment Indicated for the Signs and Symptoms of Dry Eye Disease takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the U.S. Food and Drug Administration (FDA) has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients. |
| 2016-02-04 | Takeda | Regulatory U.S. FDA Acknowledges Receipt of Resubmission of Shire’s New Drug Application for Lifitegrast for Dry Eye Disease in Adults takeda.com ↗
The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016. |
| 2016-01-25 | Takeda | Regulatory Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced it has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. |
| 2015-10-27 | Takeda | Results Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced positive topline results from OPUS-3, a phase 3 efficacy and safety study of lifitegrast versus placebo. |
| 2015-10-16 | Takeda | Regulatory Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Food and Drug Administration (FDA) requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults. |
| 2015-04-09 | Takeda | Regulatory FDA Grants Priority Review to Lifitegrast NDA for Treatment of Dry Eye Disease in Adults takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. |
| 2015-03-02 | Takeda | Regulatory Shire Submits Application to the U.S. FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the company has submitted a New Drug Application (NDA) with the U. S. Food and Drug Administration for its investigational compound lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. |
| 2014-04-30 | Takeda | Results Shire Announces Updates From Phase 3 Clinical Program For Lifitegrast In Adults With Dry Eye Disease takeda.com ↗
In addition, today the company announces top-line results from the prospective, randomized, double-masked, placebo-controlled, long-term (one-year) Phase 3 SONATA safety study. |
| 2013-12-05 | Takeda | Results Shire Reports Top-Line Results On OPUS-2, A Phase 3 Study Investigating The Use Of Lifitegrast (5.0% Ophthalmic Solution) In Adults With Dry Eye Disease takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, today announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution. |
All press releases naming this drug 22 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lifitegrast | “This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution.” NCT06879782 ↗ |
| Known as | SAR 1118 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00936520 ↗ |
| Known as | Xiidra | “Compare the pharmacokinetic (PK) profiles of Lifitegrast Ophthalmic Solution and Xiidra® in plasma and tears following single-dose administration in healthy subjects.” NCT07040826 ↗7“lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes” NCT03952481 ↗ “Xiidra® (5% lifitegrast ophthalmic solution) dosed once” NCT05102409 ↗ “(Xiidra®) Lifitegrast Ophthalmic Solution 5.0%” NCT07490535 ↗ “Lifitegrast Ophthalmic Solution 5.0% (Xiidra)” NCT07560735 ↗ |
| Action | Inhibit | “a novel integrin antagonist (SAR 1118)” PMID 22330307 ↗ Feb 2012 |
| Modality | Small molecule | “SAR 1118 is a potent and selective small molecule” NCT00936520 ↗ |
| Route | Topical | “SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily” PMID 22330307 ↗ Feb 2012 |