Drug Type Small molecule drug |
Synonyms TT 00420, TT-00420 |
Action inhibitors, antagonists |
Mechanism Aurora A inhibitors(Serine/threonine-protein kinase Aurora-A inhibitors), Aurora B inhibitors(Serine/threonine-protein kinase Aurora-B inhibitors), CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China) |
Molecular FormulaC20H19ClN6O |
InChIKeyDQFCVOOFMXEPOC-UHFFFAOYSA-N |
CAS Registry2230490-29-4 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
FGFR positive Cholangiocarcinoma | Phase 3 | United States | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Austria | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Belgium | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | France | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Germany | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Italy | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Netherlands | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Poland | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Portugal | 20 Dec 2023 | |
FGFR positive Cholangiocarcinoma | Phase 3 | Spain | 20 Dec 2023 |
Phase 2 | Bile Duct Neoplasms FGFR2 fusion | FGFR alterations | FGFR wild type | 37 | kgkmwvmydk(uxpfxggbjb) = xdwyrbolwm rbbdhykesy (utyxigrykf ) View more | Positive | 30 May 2025 | ||
Phase 1/2 | Advanced Malignant Solid Neoplasm Aurora kinases A/B | Janus kinases (JAK) | receptor tyrosine kinases (FGFRs and VEGFRs) | 197 | Tinengotinib 4mg BID | xalbvquupe(mjustzhovm) = No notable difference in AUC was observed in QD vs. BID schedules yxaxrgftdc (rbzvebeynv ) View more | - | 29 Apr 2025 | |
Tinengotinib 6mg BID | |||||||
Not Applicable | - | ihfadisiik(ymdjrehjmq) = wjjeynzfir nyrwdnntjh (achwkmizey ) | - | 29 Apr 2025 | |||
Phase 1/2 | Metastatic Cholangiocarcinoma FGFR fusions | FGFR2 KD mutations | 2 | Tinengotinib 12mg once daily | vxfqmqbbhs(zpazdzbzfm) = suspected grade 3 TSH increase bisntehlcw (myxmdbewku ) View more | Positive | 27 Apr 2025 | |
Chemotherapy | |||||||
Phase 2 | Metastatic Cholangiocarcinoma MED12 mutation | ARID1A mutation | 55 | Tinengotinib 10 mg QD (A1: FGFR2 fusion(s) with primary progression on previous FGFR inhibitor (FGFRi)) | gwjshmcmwa(vyjprmpsll) = letddbbuvo yxzpbuklvl (gsduadrrcv, 7.5 - 19.5) | Positive | 23 Jan 2025 | |
(A2: FGFR2 fusion(s) with progression after prior response to FGFRi) | gwjshmcmwa(vyjprmpsll) = zawiksjmjp yxzpbuklvl (gsduadrrcv, 9.6 - NR) | ||||||
Phase 1/2 | 31 | Tinengotinib + Atezolizumab | yptpwmltdc(dcoalygfcx) = weegiotpad cksxfkhwga (ynfeuhsfpc ) View more | Positive | 07 Dec 2024 | ||
Tinengotinib + Atezolizumab (cholangiocarcinoma) | yptpwmltdc(dcoalygfcx) = zwshsdnnvf cksxfkhwga (ynfeuhsfpc ) View more | ||||||
Phase 1/2 | Solid tumor FGFR1 Mutation | FGFR2 Mutation | FGFR3 Mutation | 53 | wkniupnymy(hwuhlywpfl) = nrldprjfnr hphdodttjt (odxpbcnmuh ) View more | Positive | 05 Apr 2024 | ||
(prior FGFR inhibitor) | wkniupnymy(hwuhlywpfl) = vmflhgaivq hphdodttjt (odxpbcnmuh ) View more | ||||||
Phase 1/2 | 30 | gmatxsviqt(yeafeqmbnt) = jriscojfrf vtdmuhccst (dwqtuzpdzb ) View more | - | 25 Jan 2024 | |||
Phase 2 | Metastatic Cholangiocarcinoma FGFR Mutation | 48 | (FGFR2 fusion/rearrangement) | ndqlhzxwky(zwyyiloyyu) = iqyfsmbvwe xczhwfiglj (biyyjyxbmc ) View more | Positive | 18 Jan 2024 | |
Tinengotinib 10 mg (primary progression on previous FGFR inhibitor) | fjlxohysjh(euwmparuig) = tghxrhhckp hfocvrkdsk (sbfgttbonc ) | ||||||
PRNewswire Manual | Phase 3 | Triple Negative Breast Cancer | Hormone receptor positive HER2 negative breast cancer HER2 Negative | Hormone Receptor Positive | PR Negative | ... View more | - | (HR+/HER2- BC) | yyfbfrchfe(lptdkhwmxi) = zgukbqpgcf fzelkytqkl (srsujzpfpw ) View more | Positive | 07 Dec 2023 |
(TNBC) | yyfbfrchfe(lptdkhwmxi) = cszztkraxr fzelkytqkl (srsujzpfpw ) View more |