Drugs / Infigratinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed achondroplasia 1 milestone | |||||
| Filed | US (FDA) | — | achondroplasia | 2026-10-06 | “accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia” bridgebio.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | TRUSELTIQ | — | 2021-05-28 | fda.gov ↗ |
Trials 31
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | Eidos Therapeutics, a BridgeBio company | Regulatory BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia bridgebio.com ↗
the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. |
| 2026-09-09 | Eidos Therapeutics, a BridgeBio company | Results Oral Infigratinib Shows Meaningful Benefits Beyond Growth Within 52 Weeks in Children with Achondroplasia in the Phase 3 PROPEL 3 Trial bridgebio.com ↗
Treatment with oral infigratinib for 52 weeks in PROPEL 3 resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events |
| 2026-06-28 | Eidos Therapeutics, a BridgeBio company | Results BridgeBio Announces Publication in the New England Journal of Medicine of Phase 3 PROPEL 3 Trial of Oral Infigratinib in Children Living with Achondroplasia bridgebio.com ↗
Oral infigratinib is the only therapy to demonstrate statistically significant improvement in body proportionality in a Phase 3 achondroplasia study, with a LS mean treatment difference of –0.05 in children ages 3 to 8 years (p<0.05) |
| 2026-02-12 | Eidos Therapeutics, a BridgeBio company | Results BridgeBio Reports Positive Phase 3 Topline Results for Oral Infigratinib with the First Statistically Significant Improvements in Body Proportionality in Achondroplasia bridgebio.com ↗
PROPEL 3 successfully met the primary endpoint of change from baseline in AHV at Week 52 (p<0.0001) |
| 2024-11-18 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma announces publication in the new england journal of medicine of phase 2 propel 2 study of infigratinib for children living with achondroplasia bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced that positive 18-month results from PROPEL 2, a Phase 2 trial of the investigational therapy infigratinib in children with achondroplasia, were published as an original research article in the New England Journal of Medicine (NEJM) today. |
| 2024-09-17 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio announces infigratinib is the first ever investigational therapeutic option for achondroplasia to be awarded breakthrough therapy designation by the fda bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that the FDA has granted Breakthrough Therapy Designation to oral infigratinib under development for children with achondroplasia. |
| 2024-06-04 | Eidos Therapeutics, a BridgeBio company | Results bridgebio announces durable month 12 and 18 phase 2 cohort 5 results of oral infigratinib in achondroplasia, and first participant consented in accel for hypochondroplasia bridgebio.com ↗
At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). |
| 2021-09-29 | Eidos Therapeutics, a BridgeBio company | Regulatory helsinn group and bridgebio pharma’s affiliate qed therapeutics announce health canada conditional approval of truseltiq™ (infigratinib) for patients with cholangiocarcinoma bridgebio.com ↗
Health Canada Issues Conditional Approval of TRUSELTIQ under Project Orbis |
| 2021-05-28 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma’s affiliate qed therapeutics and partner helsinn group announce fda approval of truseltiq™ (infigratinib) for patients with cholangiocarcinoma bridgebio.com ↗ |
| 2020-12-01 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma and affiliate qed therapeutics announce fda acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma bridgebio.com ↗
PALO ALTO, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate QED Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts. |
| 2020-05-29 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma’s qed therapeutics presents data on infigratinib in cholangiocarcinoma and urothelial carcinoma at the american society of clinical oncology 2020 virtual scientific program bridgebio.com ↗
The response rates were higher for patients with UTUC, with an ORR of 50% (95% CI 15.7–84.3) and a disease control rate of 100%. |
| 2020-05-11 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma’s qed therapeutics announces preclinical data demonstrating potential of low-dose infigratinib in achondroplasia bridgebio.com ↗
The first study, entitled “Support for a new therapeutic approach of using a low-dose FGFR tyrosine kinase inhibitor (infigratinib) for achondroplasia,” showed that in a mouse model of achondroplasia, treatment with infigratinib led to dose-dependent improvement in achondroplasia-associated phenotypes. |
| 2020-01-06 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma’s qed therapeutics receives fast track designation for infigratinib in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary QED Therapeutics announced today that it has secured both Fast Track Designation in adults with first-line advanced or metastatic cholangiocarcinoma and Orphan Drug Designation for infigratinib for treatment of cholangiocarcinoma. |
| 2019-10-17 | Eidos Therapeutics, a BridgeBio company | Results qed and parent company bridgebio announce preclinical data supporting tolerability and activity of low-dose infigratinib in treating achondroplasia bridgebio.com ↗
The data presented today showed a positive dose-response relationship between infigratinib and bone growth. |
| 2018-10-19 | Eidos Therapeutics, a BridgeBio company | Results qed therapeutics presents data for infigratinib in cholangiocarcinoma in late breaking abstract at the european society of medical oncology 2018 congress bridgebio.com ↗
Median progression free survival was 6.8 months (95% CI 95% CI 5.3-7.6) and median overall survival was 12.5 months (95% CI 9.9-16.6 months). |
All press releases naming this drug 24 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | infigratinib | “This phase IIa trial studies how well the experimental drug, BGJ398 (infigratinib), works in treating patients with fibroblast growth factor receptor (FGFR) 1-3 translocated,...” NCT02706691 ↗18“Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre,...” PMID 34358484 ↗ Aug 2021 |
| Known as | BGJ398 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02706691 ↗ |
| Known as | Infigratinib Phosphate | “Drug: Infigratinib Phosphate” NCT05514912 ↗ |
| Action | Inhibit | “a Pan FGF-R Kinase Inhibitor” NCT01004224 ↗ |
| Modality | Small molecule | “Infigratinib is an oral FGFR 1-3 kinase inhibitor.” PMID 32580579 ↗ Jun 2020 |
| Route | Oral | “Oral BGJ398” NCT01004224 ↗ |
| Target | FGFR2 | “Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.” NCT03773302 ↗ |