Lifitegrast
Lifitegrast, Xiidra (lifitegrast) is a small molecule pharmaceutical. Lifitegrast was first approved as Xiidra on 2016-07-11. It is used to treat dry eye syndromes in the USA. The pharmaceutical is active against integrin alpha-L.
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| eye diseases | D005128 |
Trade Name
FDA
EMA
Xiidra (discontinued: Lifitegrast)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lifitegrast
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XIIDRA | Bausch Health Companies | N-208073 RX | 2016-07-11 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lifitegrast | ANDA | 2023-11-13 |
| xiidra | New Drug Application | 2025-08-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| dry eye syndromes | — | D015352 | H04.12 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lifitegrast, Xiidra, Bausch And Lomb Inc | |||
| 11058677 | 2033-12-18 | DP | |
| 9085553 | 2033-07-25 | DP | |
| 8927574 | 2030-11-12 | DP | |
| 9353088 | 2030-10-21 | DP | |
| 9890141 | 2030-10-21 | DP | |
| 8168655 | 2029-05-09 | U-1880 | |
| 8367701 | 2029-04-15 | DP | U-1880 |
| 9447077 | 2029-04-15 | U-1900 | |
| 8084047 | 2026-05-17 | DS, DP | |
| 8592450 | 2026-05-17 | U-1880 | |
| 7314938 | 2025-03-10 | DS, DP | |
| 7745460 | 2024-11-05 | DS, DP | U-1880 |
| 7790743 | 2024-11-05 | U-1880 | |
| 7928122 | 2024-11-05 | DS, DP | |
| 9216174 | 2024-11-05 | DP | |
| 10124000 | 2024-11-05 | U-1900 | |
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dry eye syndromes | D015352 | — | H04.12 | 3 | 5 | 6 | 14 | 4 | 31 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | 4 | 6 | 8 | 4 | 22 |
| Eye diseases | D005128 | EFO_0003966 | H44 | 3 | 3 | 6 | 5 | 3 | 19 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | 2 | — | 3 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | — | 1 | 1 | 2 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | 1 | 1 | — | 2 |
| Contact lenses | D003261 | — | — | — | — | — | 1 | — | 1 |
| Corneal diseases | D003316 | — | H18.9 | — | — | — | 1 | — | 1 |
| Meibomian gland dysfunction | D000080343 | — | H02.88 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | — | H10 | — | 1 | — | — | — | 1 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | 1 | — | — | — | — | 1 |
| Macular edema | D008269 | — | — | 1 | — | — | — | — | 1 |
| Endophthalmitis | D009877 | — | — | 1 | — | — | — | — | 1 |
| Eye pain | D058447 | — | H57.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lifitegrast |
| INN | lifitegrast |
| Description | Lifitegrast is an N-acyl-L-alpha-amino acid obtained by formal condensation of the carboxy group of N-[2-(1-benzofuran-6-carbonyl)]-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxylic acid with the amino group of 3-(methanesulfonyl)-L-phenylalanine. Used for treatment of keratoconjunctivitis sicca (dry eye syndrome). It has a role as an anti-inflammatory drug and a lymphocyte function-associated antigen-1 antagonist. It is a L-phenylalanine derivative, a sulfone, a N-acyl-L-alpha-amino acid, a member of isoquinolines and a member of 1-benzofurans. |
| Classification | Small molecule |
| Drug class | antiasthmatics/antiallergics (not acting primarily as antihistamines): integrin antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CS(=O)(=O)c1cccc(C[C@H](NC(=O)c2c(Cl)cc3c(c2Cl)CCN(C(=O)c2ccc4ccoc4c2)C3)C(=O)O)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1025967-78-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2048028 |
| ChEBI ID | — |
| PubChem CID | 11965427 |
| DrugBank | DB11611 |
| UNII ID | 038E5L962W (ChemIDplus, GSRS) |
Target
Agency Approved
ITGAL
ITGAL
Organism
Homo sapiens
Gene name
ITGAL
Gene synonyms
CD11A
NCBI Gene ID
Protein name
integrin alpha-L
Protein synonyms
antigen CD11A (p180), lymphocyte function-associated antigen 1, alpha polypeptide, CD11 antigen-like family member A, CD11a, integrin gene promoter, integrin, alpha L (antigen CD11A (p180), lymphocyte function-associated antigen 1; alpha polypeptide), Leukocyte adhesion glycoprotein LFA-1 alpha chain, Leukocyte function-associated molecule 1 alpha chain, LFA-1 alpha, LFA-1A, lymphocyte function-associated antigen 1, alpha polypeptide
Uniprot ID
Mouse ortholog
Itgal (16408)
integrin alpha-L (Q3U159)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xiidra – Novartis
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Estimated US medical usage
Lifitegrast
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 854 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,368 adverse events reported
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