Infigratinib is an FGFR tyrosine kinase inhibitor previously marketed as Truseltiq for FGFR2 fusion/rearrangement-positive cholangiocarcinoma after prior treatment. It initially received accelerated FDA approval in 2021. In 2024, FDA announced final withdrawal of this approval and the product is discontinued.
BridgeBio shares rose 2.10% to $69.41 after Phase 3 FORTIFY interim data for oral BBP-418 in LGMD2I/R9 showed broad efficacy and placebo-matched safety. The company plans a U.S. FDA filing in H1 2026.
The FDA has cleared Abbisko Therapeutics' IND application for ABSK061, an oral FGFR2/3 inhibitor for achondroplasia, while BridgeBio reports positive Phase 3 results for its oral infigratinib in the same condition. Both companies are advancing oral therapies targeting FGFR3 overactivity in this genetic growth disorder.
The FDA approved navepegritide, a once-weekly injectable therapy for achondroplasia, while phase 3 data showed infigratinib, an investigational oral medication, achieved the highest growth velocity reported in randomized trials for the condition.
BridgeBio Pharma announced positive Phase 3 topline results for infigratinib in children with achondroplasia, meeting primary and key secondary endpoints. The company plans regulatory submissions in the U.S. and Europe in the second half of 2026.
BridgeBio Pharma reported positive Phase 3 results for oral infigratinib in children with achondroplasia, meeting primary and secondary endpoints with superior growth velocity and the first statistically significant improvement in body proportionality. The company plans regulatory submissions in the second half of 2026.
BridgeBio Pharma announced positive Phase 3 topline results for infigratinib in children with achondroplasia, meeting primary and key secondary endpoints. The company plans regulatory submissions in the U.S. and Europe in the second half of 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07393373 |
Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT06206278 |
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma |
TERMINATED | PHASE2 |
| NCT05510427 |
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification |
WITHDRAWN | PHASE1 |
| NCT05222165 |
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations |
WITHDRAWN | PHASE1/PHASE2 |
| NCT05145010 |
Extension Study of Infigratinib in Children With Achondroplasia (ACH) |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT05019794 |
Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations |
UNKNOWN | PHASE2 |
| NCT04972253 |
Phase I BLASST-3 Trial |
WITHDRAWN | PHASE1 |
| NCT04504331 |
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer |
TERMINATED | PHASE1 |
| NCT04424966 |
Infigratinib in Recurrent High-Grade Glioma Patients |
TERMINATED | EARLY_PHASE1 |
| NCT04233567 |
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations |
COMPLETED | PHASE2 |
