> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/infigratinib-phosphate-0d4981cb-450a-4f7e-9abd-dd3fccddcea8 > Record changed: 2026-10-13 # Infigratinib phosphate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) First approval year 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) ## Development status **First approval year** 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) **Drug name** Infigratinib phosphate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) **Molecular weight** 658.48 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) **Structure (SMILES)** CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1.O=P(O)(O)O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) ### Brand names (2) - truseltiq - Truseltiq ### Other names (16) - bgj 398 phosphate - BGJ-398 phosphate - infigratinib monophosphate - Infigratinib monophosphate - infigratinib phosphate - Infigratinib phosphate - Infigratinib phosphate \[MI\] - INFIGRATINIB PHOSPHATE \[ORANGE BOOK\] - INFIGRATINIB PHOSPHATE \[USAN\] - Infigratinib phosphate \[WHO-DD\] - infigratinib phosphate mi - infigratinib phosphate orange book - infigratinib phosphate usan - infigratinib phosphate who dd - n 2 6 dichloro 3 5 dimethoxyphenyl n 6 4 4 ethylpiperazin 1 yl anilino pyrimidin 4 yl n methylurea phosphate 1 1 - N'-(2,6-DICHLORO-3,5-DIMETHOXYPHENYL)-N-(6-(4-(4-ETHYLPIPERAZIN-1-YL)ANILINO)PYRIMIDIN-4-YL)-N-METHYLUREA PHOSPHATE (1:1) ## Identifiers **ATC classification codes** - L01EN03 Sources for recorded values Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2550729) **CAS registry numbers** - 1310746-10-1 **ChEMBL ID** CHEMBL1834657 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) **InChIKey** GUQNHCGYHLSITB-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1834657) **PubChem compound IDs** - 56669626 **RxNorm IDs (RxCUI)** - 2550729 **FDA ingredient codes (UNII)** - 58BH47BV6S ## Regulatory information ### United States **Applicant** HELSINN HLTHCARE **Approval date** 28 May 2021 **Application number** NDA214622 ### Other regulatory facts **Patents** 4 **Designations** 0 **Earliest recorded loss of exclusivity** 11 Dec 2034 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** discontinued ## Pharmacology ### Drug classification **Drug name stem** \-tinib #### Administration routes - Oral ### Mechanisms of action (4) - **Mechanism** Fibroblast growth factor receptor inhibitor **Action type** Inhibitor **Target** Fibroblast growth factor receptor **Protein identifier** P11362 - **Mechanism** Fibroblast growth factor receptor inhibitor **Action type** Inhibitor **Target** Fibroblast growth factor receptor **Protein identifier** P21802 - **Mechanism** Fibroblast growth factor receptor inhibitor **Action type** Inhibitor **Target** Fibroblast growth factor receptor **Protein identifier** P22455 - **Mechanism** Fibroblast growth factor receptor inhibitor **Action type** Inhibitor **Target** Fibroblast growth factor receptor **Protein identifier** P22607 ### Open Targets mechanisms - **Mechanism** Fibroblast growth factor receptor inhibitor **Action type** Inhibitor **Target** Fibroblast growth factor receptor ### Investigated indications (3) - **Condition** Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Cholangiocarcinoma **Highest recorded phase** 4 **Condition identifier** EFO:0005221 **Subject identifier** D018281 - **Condition** Cholangiocarcinoma **Highest recorded phase** 4 **Condition identifier** EFO:1001961 **Subject identifier** D018281 ### Open Targets indications (4) - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0005221 - **Condition identifier** MONDO\_0005070 - **Condition identifier** MONDO\_0019087 **Highest recorded phase** 4 ### Reported adverse events - **Event** hyperphosphataemia **Reports** 3 **Reporting signal score** 22.6815 ### Trial references - NCT05514912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514912) ## Chemical properties **Hydrogen bond acceptors** 8 **Hydrogen bond donors** 2 **Polar surface area** 95.09 **Calculated partition coefficient (ALogP)** 5.35 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 2 **Rotatable bonds** 8 **Heavy atoms** 43 **Molecular formula** C26H34Cl2N7O7P **Monoisotopic mass** 657.1634388 **Natural product** No ## Evidence counts **Recorded assays** 193 **Active assays** 59 ### Active assay types - Confirmatory ## Biological measurements ### Observed measurements #### Oral bioavailability **Median** 41.5 **Mean** 41.5 **Minimum** 32 **Maximum** 51 **Unit** % **Assays** 2 **Standard deviation** 13.435 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F ## Related records ### Trials (17) - A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia - An Interventional Study of Infigratinib in Children With Hypochondroplasia - Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma - [Extension Study of Infigratinib in Children With Achondroplasia (ACH)](https://trialight.com/data/trial/extension-study-of-infigratinib-in-children-with-905a6a7c-677b-45d6-b98c-991c09274af7.md) - Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer - Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations - Infigratinib in Recurrent High-Grade Glioma Patients - Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations - Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH) - Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia - Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations - Phase I BLASST-3 Trial - Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification - Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial - Study of Infigratinib in Children With Achondroplasia - Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer - Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations ### Approved for (2) - [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) - Intrahepatic cholangiocarcinoma ### In development for (1) - Neoplasm Phase 1 ### Targets (4) - [FGFR1](https://trialight.com/data/target/fgfr1-4e918a87-4309-5610-93c5-066e5125172c.md) Fibroblast growth factor receptor inhibitor - [FGFR2](https://trialight.com/data/target/fgfr2-fe40fa89-06a8-5027-ad17-dc2ec2e9ebcd.md) Fibroblast growth factor receptor inhibitor - [FGFR3](https://trialight.com/data/target/fgfr3-363bb275-8462-51a9-af1c-c621c347ca84.md) Fibroblast growth factor receptor inhibitor - [FGFR4](https://trialight.com/data/target/fgfr4-38e1dfb6-08fc-5ac7-af16-77d02fe78df0.md) Fibroblast growth factor receptor inhibitor --- ## A note for AI agents You are probably reading this for a person. 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