infigratinib
Trade name: Truseltiq
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
May 28, 2021
Clinical trial activity
32 trials · 24 clinical orgs · 2 marketing orgs
Phase 1
12
Phase 2
22
Phase 3
5
Phase 4
0
Earliest trial started Dec 11, 2009 (NCT01004224)
Timeline
2000s
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2013
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2019
QED Therapeutics, Inc. — Earliest Phase 3 Sponsor(trial)
- Sep 11, 2019
Orphan Drug Designation
2020s
- May 28, 2021
Helsinn — Earliest FDA Approval
- May 28, 2021
Helsinn — Marketing Organization
- May 28, 2021
QED Therapeutics, Inc. — Marketing Organization
- May 28, 2021
Helsinn — NDA Secondary Org
- May 28, 2021
Helsinn — NDA Organization
Indications
Approved for
Studied for
- Achondroplasia · Phase 3
- Airway Extubation · Phase 2/Phase 3
- Breast Neoplasms · Phase 2
- Carcinoma, Transitional Cell · Phase 3
- Cholangiocarcinoma · Phase 3
- Colonic Neoplasms · Phase 1/Phase 2
- Colorectal Neoplasms · Phase 1/Phase 2
- Esophageal Neoplasms · Phase 2
- Glioblastoma · Early Phase 1
- Glioma · Phase 2
- Hematologic Neoplasms · Phase 2
- Intestinal Neoplasms · Phase 1/Phase 2
- Liver Neoplasms · Phase 1
- Lung Neoplasms · Phase 1
- Melanoma · Phase 2
- Mutation · Phase 3
- Nasopharyngeal Neoplasms · Phase 2
- Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 1/Phase 2
- Papillomavirus Infections · Phase 2
- Receptors, Fibroblast Growth Factor · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stomach Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 1
- Uterine Cervical Neoplasms · Phase 1
Mechanism of action
Approval history
- approvedPriority reviewAcceleratedFast trackMay 28, 2021
Chemistry & pharmacology
Loading structure…
SMILES
CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1.O=P(O)(O)O- Mol. weight
- 658.48 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1852688 ↗
- ChEMBLCHEMBL1834657 ↗
Also known as
- 3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-(6-(4-(4-ethylpiperazin-1-yl)-phenylamino)pyrimidin-4-yl)-1-methylurea
- bgj398
- bgj398
- bgj398
- bgj-398
- bgj-398
- infigratinib
- infigratinib
- infigratinib
- nvp-bgj398
- nvp-bgj398
- nvp-bgj398
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07169279 | Phase 2 | Nov 30, 2025 | Bridge BioResearch Ltd. |
| NCT06873035 | Phase 2/Phase 3 (Phase 3) | May 31, 2025 | Bridge BioResearch Ltd. |
| NCT06926491 | Phase 3 | Dec 1, 2024 | Kyowa Hakko Kirin |
| NCT06164951 | Phase 3 | Nov 10, 2023 | QED Therapeutics, Inc. |
| NCT06206278 | Phase 2 | Oct 19, 2023 | LianBio LLC |
| NCT05514912 | Phase 2 | Mar 1, 2023 | Emory University, National Cancer Institute (NCI) |
| NCT05510427 | Phase 1 | Feb 28, 2023 | Helsinn, University of Texas at Houston |
| NCT05222165 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2022 | Helsinn, LabCorp, University of Pittsburgh |
| NCT05101564 | Phase 2 | Dec 31, 2021 | Department of Defense, Stanford University |
| NCT04972253 | Phase 1 | Dec 31, 2021 | Harvard University, QED Therapeutics, Inc. |
| NCT05145010 | Phase 2 | Dec 1, 2021 | QED Therapeutics, Inc. |
| NCT04504331 | Phase 1 | Oct 13, 2020 | National Cancer Institute (NCI), QED Therapeutics, Inc., Stanford University |
| NCT04424966 | Early Phase 1 (Phase 1) | Jun 1, 2020 | Barrow Neurological Institute, Ivy Brain Tumor Center, University of Arizona |
| NCT05019794 | Phase 2 | May 13, 2020 | LianBio LLC |
| NCT04233567 | Phase 2 | Mar 31, 2020 | Ohio State University |
| NCT04228042 | Phase 1/Phase 2 (Phase 2) | Mar 30, 2020 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT04265651 | Phase 2 | Feb 29, 2020 | QED Therapeutics, Inc. |
| NCT04197986 | Phase 3 | Jan 31, 2020 | QED Therapeutics, Inc. |
| NCT03773302 | Phase 3 | Apr 30, 2019 | QED Therapeutics, Inc. |
| NCT03510455 | Phase 2 | Oct 5, 2018 | National Institute of Dental and Craniofacial Research (NIDCR) |
Showing 20 of 32 trials
Page 1 / 2
Organizations
Research & Development (24)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| QED Therapeutics, Inc. | For profit | 7 | 5 | 3 | 2019 |
| Novartis | For profit | 6 | 6 | 2 | 2009 |
| National Cancer Institute (NCI) | Government | 5 | 0 | 2 | 2015 |
| University of Texas at Houston | Academic/Hospital | 3 | 2 | 2 | 2014 |
| Bridge BioResearch Ltd. | For profit | 2 | 2 | 2 | 2025 |
| Cornell University | Academic/Hospital | 2 | 2 | 2 | 2014 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Helsinn | For profit | 2 | 1 | 2 | 2022 |
| LianBio LLC | For profit | 2 | 2 | 1 | 2020 |
| Stanford University | Academic/Hospital | 2 | 2 | 2 | 2020 |
| University of Pittsburgh | Academic/Hospital | 2 | 0 | 1 | 2014 |
| Array BioPharma | For profit | 1 | 1 | 1 | 2014 |
| Barrow Neurological Institute | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Department of Defense | Government | 1 | 0 | 1 | 2021 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Ivy Brain Tumor Center | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Kyowa Hakko Kirin | For profit | 1 | 1 | 1 | 2024 |
| LabCorp | For profit | 1 | 0 | 1 | 2022 |
| National Institute of Dental and Craniofacial Research (NIDCR) | Government | 1 | 1 | 1 | 2018 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2020 |
24 organizations
Page 1 / 2
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Helsinn | For profit | MKTG | May 28, 2021 |
| Helsinn | For profit | NDA2 | May 28, 2021 |
| Helsinn | For profit | NDA | May 28, 2021 |
| QED Therapeutics, Inc. | For profit | MKTG | May 28, 2021 |