MedPath

Lifitegrast

Generic Name
Lifitegrast
Brand Names
Xiidra
Drug Type
Small Molecule
Chemical Formula
C29H24Cl2N2O7S
CAS Number
1025967-78-5
Unique Ingredient Identifier
038E5L962W

Overview

Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting .

Indication

适用于治疗干眼病(DED)的症状和体征。

Associated Conditions

  • Dry Eye Syndrome (DES)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/27
Not Applicable
Completed
2023/05/15
N/A
Withdrawn
2022/10/26
Phase 4
Completed
Tauber Eye Center
2022/08/17
Phase 4
Completed
State University of New York College of Optometry
2021/11/01
Phase 2
Completed
2021/09/16
Phase 4
UNKNOWN
2021/03/11
Early Phase 1
Completed
Richard W Yee, MD
2021/02/02
Phase 2
Completed
2020/12/17
Phase 4
Completed
2020/06/02
Phase 4
Terminated
Eye Surgeons of Indiana

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bausch & Lomb Incorporated
24208-911
OPHTHALMIC
50 mg in 1 mL
1/2/2024
Novartis Pharmaceuticals Corporation
0078-0911
OPHTHALMIC
50 mg in 1 mL
7/31/2020
Aurobindo Pharma Limited
59651-450
OPHTHALMIC
50 mg in 1 mL
11/13/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
XIIDRA lifitegrast 50 mg/mL eye drops single-use ampoules
293589
Medicine
A
1/21/2019

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
XIIDRA
bausch & lomb inc
02471027
Solution - Ophthalmic
5 % / W/V
2/12/2018

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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