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

NeoplasmsOther DiseasesDigestive System Disorders+ [4]

Active Indication

Advanced Bile Duct CarcinomaCarcinoma bile duct non-resectableFGFR2 fusion or rearranged Cholangiocarcinoma+ [21]

Inactive Indication

Locally Advanced Malignant Solid NeoplasmSarcoma

Originator Organization

TransThera Sciences (Nanjing), Inc.

Active Organization

TransThera Sciences (Nanjing), Inc.

Inactive Organization-

License Organization

Roche Holding AG

TransThera Sciences (Nanjing), Inc.

Drug Highest PhaseApproved

First Approval Date

China (04 Aug 2026),

Advanced Bile Duct CarcinomaCarcinoma bile duct non-resectableFGFR2 fusion or rearranged Cholangiocarcinoma+ [1]

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC20H19ClN6O

InChIKeyDQFCVOOFMXEPOC-UHFFFAOYSA-N

CAS Registry2230490-29-4

Clinical Trials associated with Tinengotinib

CTR20262469

/ RecruitingPhase 1

一项评价替恩戈替尼在肝功能不全和肝功能正常参与者中药代动力学特征的开放标签、非随机、单次给药、平行分组的I期临床研究

[Translation] An open-label, non-randomized, single-dose, parallel-group phase I clinical study evaluating the pharmacokinetic characteristics of entagoguetinib in participants with hepatic impairment and normal hepatic function.

主要目的：与匹配的对照健康参与者相比，评价替恩戈替尼在不同程度肝功能不全参与者中的药代动力学（PK）特征次要目的：与匹配的对照健康参与者相比，评价替恩戈替尼在不同程度肝功能不全参与者中的安全性和耐受性

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) characteristics of tengotinib in participants with varying degrees of hepatic impairment, compared with matched healthy control participants. Secondary objective: To evaluate the safety and tolerability of tengotinib in participants with varying degrees of hepatic impairment, compared with matched healthy control participants.

Start Date17 Jul 2026

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

NCT07498478

/ RecruitingPhase 2

A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are:
1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?
2. What medical problems do participants have when taking the combination therapy?
Participants will:
Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A.
In Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.

Start Date17 Mar 2026

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

NCT07328919

/ Not yet recruitingPhase 3

A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy

This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.

Start Date01 Jan 2026

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

100 Clinical Results associated with Tinengotinib

100 Translational Medicine associated with Tinengotinib

100 Patents (Medical) associated with Tinengotinib

Literatures (Medical) associated with Tinengotinib

01 Feb 2026·The Lancet Gastroenterology & Hepatology

Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial

Article

Author: Sahai, Vaibhav ; Richards, Donald ; Peng, Peng ; Cohn, Allen ; Javle, Milind ; Ni, Shumao ; Sun, Caixia ; Fountzilas, Christos ; Pelster, Meredith ; Fonkoua, Lionel Kankeu ; Wang, Hui ; Li, Daneng ; Kingsley, Edwin ; Fan, Jean ; Liao, Chih-Yi ; Deming, Dustin ; Mahipal, Amit ; Hennessy, Katie ; Wu, Frank ; Mantry, Parvez

BACKGROUND:

Cholangiocarcinoma is a rare, aggressive cancer often driven by FGFR2 fusions, which are targetable with inhibitors such as pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this study, we aimed to evaluate the efficacy and safety of tinengotinib in previously treated patients with advanced cholangiocarcinoma.

METHODS:

This open-label, multicentre, phase 2 trial was done at 32 medical centres in the USA. Eligible patients were aged 18 years or older with advanced or metastatic cholangiocarcinoma, who had previous systemic chemotherapy, and an Eastern Cooperative Oncology Group score of 0-1. Patients were assigned to one of four cohorts on the basis of FGFR status: cohort A1, FGFR2 fusions with primary FGFR inhibitor resistance; cohort A2, FGFR2 fusions with acquired FGFR inhibitor resistance; cohort B, other FGFR alterations; or cohort C, FGFR wild-type. Patints orally self-administered tinengotinib 10 mg daily in 28-day cycles in 28-day treatment cycles until documented disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was objective response rate as per investigator assessment, defined as the proportion of patients with confirmed tumour response (complete response or partial response) that was redocumented 4 weeks or after initial assessment based on RECIST (version 1.1), as assessed by the investigator. The primary endpoint was assessed in the in the efficacy evaluable population, which included all patients who received at least one dose of tinengotinib, had measurable disease at baseline, and had at least one post-baseline tumour assessment. Safety assessed in all patients who received at least one dose of tinengotinib. This trial is registered with ClinicalTrials.gov, NCT04919642, and enrolment is complete.

FINDINGS:

Between Nov 19, 2021, and March 5, 2024, 55 patients were enrolled and assigned to one of four cohorts (cohort A1 [n=18], cohort A2 [n=11], cohort B [n=13], and cohort C [n=13]); all received tinengotinib. Patients had a median age of 61 years (IQR 56-68); 31 (56%) patients were female. All patients had received at least one previous systemic therapy. Median follow-up was 11·3 months (IQR 6·5-17·3). Among 51 patients included in the efficacy evaluable set, the objective response rate was 6·3% (95% CI 0·2-30·2; one confirmed partial response) in cohort A1, 30·0% (6·7-65·3; three confirmed partial responses) in cohort A2, 23·1% (5·0-53·8; three confirmed partial responses) in cohort B, and 0% in cohort C. Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. Grade 4 treatment-related adverse events occurred in two (4%) of 55 patients (increased lipase [n=1] and posterior reversible encephalopathy syndrome [n=1]); no grade 5 treatment-related adverse events were reported.

INTERPRETATION:

These findings suggest that tinengotinib might have activity in patients with cholangiocarcinoma with FGFR2 fusions that progressed following FGFR inhibitor therapy. Anti-tumour activity was also observed in patients with other FGFR alterations. The data from this phase 2 study supported the initiation of a phase 3 registration trial.

FUNDING:

TransThera Sciences.

01 Apr 2025·CANCER SCIENCE

Multiple Kinase Small Molecule Inhibitor Tinengotinib (TT‐00420) Alone or With Chemotherapy Inhibit the Growth of SCLC

Article

Author: Peng Peng ; Yuanhua Lu ; Rui Zhong ; Chenchen Tang ; Ying Cheng ; Hui Li ; Shaowei Lan ; Xiaoyan Qiang ; Yan Liu ; Chunjiao Wu ; Ying Liu ; Peiyan Zhao ; Frank Wu ; Rixin Li

ABSTRACT:

There is an urgent need to develop new targeted treatment agents for small cell lung cancer (SCLC). Tinengotinib (TT‐00420) is a novel, multi‐targeted, and spectrally selective small‐molecule kinase inhibitor that has shown significant inhibitory effects on certain solid tumors in preclinical studies. However, its role and mechanism of action in SCLC remain unclear. In this study, we demonstrated that tinengotinib effectively inhibited SCLC cell proliferation, especially highly expressing NeuroD1 (SCLC‐N), in the SCLC cell line‐derived xenograft (CDX) model and the malignant pleural effusion cell model of patients with SCLC. When combined with etoposide/cisplatin, it synergistically inhibited SCLC growth. Tinengotinib regulates proliferation, apoptosis, migration, cell cycle and angiogenesis in SCLC cells. Mechanistic studies revealed that c‐Myc expression may be a key factor influencing the effect of tinengotinib in SCLC‐N. This study provides reliable preclinical data and a new direction for tinengotinib as a promising therapy for SCLC, either alone or in combination with chemotherapy.

01 Apr 2025·ANNALS OF ONCOLOGY

A model for decoding resistance in precision oncology: acquired resistance to FGFR inhibitors in cholangiocarcinoma

Article

Author: Qiang, X ; Borad, M ; Kambadakone, A R ; Shroff, R T ; Danysh, B P ; Flaherty, K T ; Leshchiner, I ; Martin, E E ; DiToro, D ; Lennerz, J K ; Saha, S K ; Lin, B ; Javle, M ; Chen, C T ; Iyer, R ; Sun, C ; Friboulet, L ; Harris, T ; Wang, H ; Reyes, S ; Li, L ; Cleary, J M ; Stone, J R ; Fan, J ; Gordan, J D ; Karasic, T ; Bensen, D C ; Iyer, S ; Kelley, R K ; Hoffman, I D ; Berchuck, J E ; Maurer, J ; Sootome, H ; Damjanov, N ; Baiev, I ; Goyal, L ; Peng, P ; Uboha, N V ; Wehrenberg-Klee, E ; Mody, K ; Parida, L ; Getz, G ; Walmsley, C ; Hollebecque, A ; Juric, D ; Nelson, K J ; Harris, W ; Majeed, U ; Zhang, K ; Zhu, A X ; Wu, F ; Facchinetti, F ; Vasseur, D ; Hirai, H ; Pinto, C

BACKGROUND:

Fibroblast growth factor receptor (FGFR) inhibitors have significantly improved outcomes for patients with FGFR-altered cholangiocarcinoma, leading to their regulatory approval in multiple countries. As with many targeted therapies, however, acquired resistance limits their efficacy. A comprehensive, multimodal approach is crucial to characterizing resistance patterns to FGFR inhibitors.

PATIENTS AND METHODS:

This study integrated data from six investigative strategies: cell-free DNA, tissue biopsy, rapid autopsy, statistical genomics, in vitro and in vivo studies, and pharmacology. We characterized the diversity, clonality, frequency, and mechanisms of acquired resistance to FGFR inhibitors in patients with FGFR-altered cholangiocarcinoma. Clinical samples were analyzed longitudinally as part of routine care across 10 institutions.

RESULTS:

Among 138 patients evaluated, 77 met eligibility, yielding a total of 486 clinical samples. Patients with clinical benefit exhibited a significantly higher rate of FGFR2 kinase domain mutations compared with those without clinical benefit (65% versus 10%, P < 0.0001). We identified 26 distinct FGFR2 kinase domain mutations, with 63% of patients harboring multiple. While IC50 assessments indicated strong potency of pan-FGFR inhibitors against common resistance mutations, pharmacokinetic studies revealed that low clinically achievable drug concentrations may underly polyclonal resistance. Molecular brake and gatekeeper mutations predominated, with 94% of patients with FGFR2 mutations exhibiting one or both, whereas mutations at the cysteine residue targeted by covalent inhibitors were rare. Statistical genomics and functional studies demonstrated that mutation frequencies were driven by their combined effects on drug binding and kinase activity rather than intrinsic mutational processes.

CONCLUSION:

Our multimodal analysis led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. FGFR inhibitors should be small, high-affinity, and selective for specific FGFR family members. Tinengotinib, a novel small molecule inhibitor with these characteristics, exhibited preclinical and clinical activity against key resistance mutations. This integrated approach offers a blueprint for advancing drug resistance research across cancer types.

News (Medical) associated with Tinengotinib

07 Aug 2026

·www.prnewswire.com

Yochanra®, the World's First Innovative Drug to Overcome FGFR Inhibitor Resistance, Makes Its Global Debut in China

NANJING, China and GAITHERSBURG, Md., Aug. 7, 2026 /PRNewswire/ -- TransThera Sciences' Yochanra® is the first drug independently developed in China to address the longstanding global challenge of acquired resistance to FGFR inhibitor therapy in patients with cholangiocarcinoma. On 6 August 2026, the National Medical Products Administration (the "NMPA") formally approved the drug for marketing. As a global frontrunner in this field, the product had previously been granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (the "FDA"), Orphan Drug Designation for the treatment of biliary tract cancer by the European Medicines Agency (the "EMA"), and inclusion in the List of Products for Priority Review and the List of Breakthrough Therapeutic Drugs by the NMPA in China. The product has also been featured and presented orally on multiple occasions at leading international scientific conferences, filling the clinical gap arising from the absence of a standard treatment following the development of resistance to FGFR inhibitor therapy. The indication approved by the NMPA is the first indication under the multi-indication development strategy for Yochanra®. It is indicated for adult patients with advanced, metastatic or unresectable cholangiocarcinoma harboring an FGFR2 fusion or rearrangement who have previously received systemic therapy and FGFR inhibitor therapy. The approval of this indication was based on a multicenter, open-label, single-arm, pivotal Phase II clinical trial conducted in China. The results of the study were presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO). As of 27 December 2025, with a median follow-up of 12 months, all 50 patients with advanced cholangiocarcinoma enrolled in the study had previously received at least one line of chemotherapy and treatment with one FGFR inhibitor. Assessments by blinded independent central review (BICR) showed that: The objective response rate (ORR) was 28.0%, with 14 patients achieving a confirmed partial response. The median duration of response (DoR) was 8.5 months (95% CI: 5.6~12.5 months), and the disease control rate (DCR) was 82.0%. The median progression-free survival (PFS) was 6.0 months (95% CI: 4.4~8.3 months). The median overall survival (OS) was 20.7 months (95% CI: 11.8 months ~ not estimable). In the trial, Yochanra® demonstrated durable antitumor activity and a manageable safety and tolerability profile. The global market for cholangiocarcinoma therapeutics reached US$2.0 billion in 2024 and is projected to grow to US$3.2 billion by 2027, with approximately 25.2% of patients with cholangiocarcinoma harboring FGFR alterations. According to a research paper published in "Cancer Treatment Reviews" in 2023, patients with cholangiocarcinoma develop acquired resistance following FGFR inhibitor treatment. Patients who develop resistance typically harbor at least one, and often multiple, mutations, creating extremely high barriers to drug development in this field. Several overseas biotech companies have initiated related research programs, but such programs ultimately ended in failure. Neither Chinese nor U.S. treatment guidelines provide any high-level recommendation for the treatment of patients with cholangiocarcinoma who have developed resistance, leaving such patients without an established standard treatment option. Through its unique FGFR-binding mode, Yochanra® can overcome resistance mutations at multiple sites while maintaining high binding activity. Clinical trials have demonstrated that it can effectively overcome acquired resistance, bringing new hope to patients with FGFR2 fusion- or rearrangement-positive cholangiocarcinoma who have developed resistance to prior FGFR inhibitor therapy. This marketing approval marks the approval in China of the first indication for Yochanra®. Meanwhile, for cholangiocarcinoma, enrollment has been completed in the global multicenter registrational Phase III study of Yochanra®, while the Phase III confirmatory study in China is progressing in parallel. For other indications, the Company will continue to advance clinical trials at various stages, with a view to providing potentially better clinical treatment options for more patients, including, but not limited to, patients with prostate cancer, breast cancer and liver cancer. ABOUT YOCHANRA ® Yochanra® (Tinengotinib) is an innovative multi-target small-molecule kinase inhibitor independently developed by the Company targeting FGFR/VEGFR, JAK and Aurora kinases. It exerts antitumor effects through three mechanisms: precision targeting, lineage remodeling and immune activation. Yochanra® is currently being evaluated in multiple clinical trials conducted globally for solid tumors including cholangiocarcinoma, prostate cancer, breast cancer and liver cancer. It has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA for the treatment of cholangiocarcinoma and Orphan Drug Designation by the EMA for the treatment of biliary tract cancer. ABOUT TRANSTHERA TransThera is a biopharmaceutical company that focuses on clinical needs. It is dedicated to discovering and developing small molecule innovative therapies for tumors, inflammation, and cardiometabolic diseases. Further aided by in-depth study of translational medicine and drug design, TransThera aims to develop first-in-class or best-in-class drug candidates strategically positioned to meet urgent clinical needs on a global scale. SOURCE TransThera Sciences (Nanjing) Inc. 21% more press release views with Request a Demo

Clinical ResultOrphan DrugPhase 3Fast TrackDrug Approval

07 Aug 2026

·firstwordpharma.com

China OKs world's first therapy tackling FGFR inhibitor resistance in biliary cancer

China's National Medical Products Administration (NMPA) on Thursday granted conditional approval to TransThera Sciences' Yochanra (tinengotinib) for adults with advanced, metastatic or unresectable cholangiocarcinoma harbouring a fibroblast growth factor receptor2 (FGFR2) fusion or rearrangement who have previously received systemic therapy and FGFR inhibitor treatment.TransThera said the authorisation makes Yochanra — a small-molecule kinase inhibitor targeting FGFR/VEGFR, Janus kinase (JAK) and Aurora kinases — the world's first therapy designed to overcome FGFR inhibitor resistance and the first independently developed therapy in China for this setting.The approval, granted under priority review, was backed by a single-arm Phase II trial conducted in China, whose findings were presented at the American Society of Clinical Oncology (ASCO) annual meeting earlier this year. Results, as of the Dec. 27, 2025 cutoff, showed an objective response rate of 28%, a median duration of response of 8.5 months and a disease control rate of 82%. Additionally, the median progression-free survival was 6.0 months, while median overall survival reached 20.7 months.Yochanra previously received Orphan Drug Designations from the FDA and the EMA, as well as a Fast Track designation from the former. Meanwhile, the company is conducting a global late-stage registrational study, alongside a parallel Chinese confirmatory trial of Yochanra for the cholangiocarcinoma indication. Moreover, the drug is also being investigated in other solid tumours, including prostate, breast and liver cancer.

Clinical ResultOrphan DrugPhase 2Fast TrackDrug Approval

26 May 2026

·allsci.com

TransThera, Allist to test out AXL/FLT3 inhibitor with EGFRi against NSCLC

TransThera Sciences (Nanjing), Inc. (HKEX: 2617) and Shanghai Allist Pharmaceuticals Co., Ltd. (SSE: 688578) have entered a clinical trial collaboration and supply agreement to run a Phase II study combining TransThera’s dual AXL/FLT3 inhibitor TT-00973-MS with Allist’s third-generation EGFR tyrosine kinase inhibitor firmonertinib mesylate in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR-sensitive mutations. Under the agreement, TransThera will sponsor and fund the Phase II study, while Allist will supply firmonertinib free of charge. Financial terms were not disclosed. Deal context TT-00973-MS is described by TransThera as an internally developed dual inhibitor of AXL and FLT3 receptor tyrosine kinases. AXL upregulation is a documented mechanism of acquired resistance to EGFR-targeted therapy in NSCLC, and preclinical data cited by the company show activity in AXL-overexpressing xenograft models. TransThera completed a Phase I trial of TT-00973-MS in patients with solid tumors as of December 31, 2025, reporting tolerability and responses in some patients; no detailed efficacy or pharmacokinetic data were disclosed in the announcement. Firmonertinib mesylate is a third-generation EGFR-TKI developed by Allist, positioned in the same class as osimertinib. The drug holds Breakthrough Therapy Designation from both China’s National Medical Products Administration and the US FDA across several EGFR mutation subtypes, including exon 20 insertion mutations and EGFR PACC mutations. The combination rationale is mechanism-based: firmonertinib suppresses EGFR-driven tumor growth while TT-00973-MS targets the AXL pathway that commonly mediates escape from EGFR inhibition. The planned Phase II study is multi-center and open-label. Both parties have indicated intent to use Phase II results as the basis for deciding whether to jointly advance a Phase III trial, though no formal option rights or financial terms for that potential next stage have been defined. TransThera has pursued a broader strategy of testing its kinase inhibitors in combination regimens across multiple tumor types. The company dosed the first patient in a Phase II trial of tinengotinib combined with fulvestrant in previously treated HR+/HER2-negative relapsed or metastatic breast cancer in March 2026, and in the same month received Phase II approval for tinengotinib combined with novel hormone therapy in metastatic castration-resistant prostate cancer in China. In April 2026, the company dosed the first patient in a confirmatory Phase III trial of tinengotinib monotherapy for advanced cholangiocarcinoma. Industry and transaction context The scientific premise of pairing an AXL inhibitor with an EGFR-TKI to address resistance has attracted attention across the industry. Bemcentinib, an AXL inhibitor developed by BerGenBio, has been evaluated in combination with osimertinib in EGFR-mutant NSCLC in investigator-led studies, though that program has not advanced to a pivotal trial. The TT-00973-MS program is differentiated by its dual AXL/FLT3 profile, though the clinical relevance of FLT3 inhibition in this NSCLC context is not established in published literature independent of TransThera’s materials. The EGFR-TKI combination space in China has seen sustained activity. Innovent Biologics (HKEX: 01801) and ASK Pharma received NMPA approval for limertinib, another third-generation EGFR-TKI, for first-line NSCLC treatment in April 2025, illustrating the competitive density of the class in China. Hansoh Pharma (HKEX: 03692) also received Breakthrough Therapy Designation from the NMPA for its fourth-generation EGFR-TKI HS-10504 in May 2026, reflecting continued investment in next-generation agents designed to address resistance to current third-generation drugs. That competitive context reinforces the rationale for combination strategies that target resistance mechanisms in parallel with EGFR inhibition, rather than relying on sequential monotherapy switching. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 2Breakthrough TherapyDrug ApprovalPhase 3Phase 1

100 Deals associated with Tinengotinib

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Bile Duct Carcinoma	China	TransThera Sciences (Nanjing), Inc.	04 Aug 2026
Carcinoma bile duct non-resectable	China	TransThera Sciences (Nanjing), Inc.	04 Aug 2026
FGFR2 fusion or rearranged Cholangiocarcinoma	China	TransThera Sciences (Nanjing), Inc.	04 Aug 2026
Metastatic Cholangiocarcinoma	China	TransThera Sciences (Nanjing), Inc.	04 Aug 2026

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
FGFR2 positive Intrahepatic Cholangiocarcinoma	Phase 3	China	TransThera Sciences (Nanjing), Inc.	07 Apr 2026
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	China	TransThera Sciences (Nanjing), Inc.	01 Jan 2026
FGFR positive Cholangiocarcinoma	Phase 3	United States	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Austria	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Belgium	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	France	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Germany	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Italy	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Netherlands	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Poland	TransThera Sciences (Nanjing), Inc.	20 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04919642 (Pubmed \| Lancet Gastroenterol Hepatol)	Phase 2	Metastatic Cholangiocarcinoma	55	Tinengotinib (FGFR2 fusions with acquired FGFR inhibitor resistance)	rbhxhcocxx(sqhrdddzrr) = Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. pomjhdewex (gefjnotort ) View more	Positive	01 Dec 2025
NCT03654547 (ESMO2025)	Phase 1/2	Advanced Bile Duct Carcinoma FGFR2-altered	109	Tinengotinib	sezsgqwhjr(hvdgdbrgih) = xwrjqgvvvm gfncgmgkqu (irkjjkaiis ) View more	Positive	17 Oct 2025
				Tinengotinib (FGFR2-altered)	slpmmhtunn(awlazuekdf) = crkuxymoke kwkzcrazal (pjqtljeouj, 9.43 - 19.48) View more
NEWS Manual	Not Applicable	Bile Duct Neoplasms	43	Tinengotinib	xnsjijcfvn(czifzrjwwt) = ijbkqjsvul pbeeqflftn (ursotuzxrc ) View more	Positive	13 Jul 2025
NCT04919642 (TransThera's phase 2, ASCO2025)	Phase 2	Bile Duct Neoplasms FGFR2 fusion \| FGFR alterations \| FGFR wild type	37	Tinengotinib	rpxnfdwmli(hdrnnyryov) = cheiiipvtu ifbmhwqgka (jswhmhaepk ) View more	Positive	30 May 2025
NCT04742959 (AACR2025)	Phase 1/2	Advanced Malignant Solid Neoplasm Aurora kinases A/B \| Janus kinases (JAK) \| receptor tyrosine kinases (FGFRs and VEGFRs)	197	Tinengotinib 4mg BID	wwlvwlqllh(egxoprkdjr) = No notable difference in AUC was observed in QD vs. BID schedules voxvndprtn (ltmvceelcy ) View more	-	29 Apr 2025
				Tinengotinib 6mg BID
NCT04742959 (AACR2025)	Phase 1/2	Metastatic Cholangiocarcinoma FGFR fusions \| FGFR2 KD mutations	2	Tinengotinib 12mg once daily	eqicnhjxuu(vgprpvpqib) = suspected grade 3 TSH increase nbcwuyyusn (ehmexhmjtk ) View more	Positive	27 Apr 2025
				Chemotherapy
NCT04919642 (ASCO_GI2025) Manual	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))	dcnxsdqvxo(xlwnspoqlw) = zqwjclwgok ihtctmtjdw (qiyialqyjh, 7.5 - 19.5)	Positive	23 Jan 2025
				Tinengotinib 10 mg QDTinengotinib 10 mg QD (A2: FGFR2 fusion(s) with progression after prior response to FGFRi)	dcnxsdqvxo(xlwnspoqlw) = khcdgmthei ihtctmtjdw (qiyialqyjh, 9.6 - NR)
NCT05253053 (TT-00420, ESMO_ASIA2024) Manual	Phase 1/2	Biliary Tract Neoplasms	31	Tinengotinib + Atezolizumab	oribqalvwg(moquhuagsv) = cfkaakpojh vrkfeeybhg (jwygsaabuq ) View more	Positive	07 Dec 2024
				Tinengotinib + Atezolizumab (cholangiocarcinoma)	oribqalvwg(moquhuagsv) = ycdpzgcqtk vrkfeeybhg (jwygsaabuq ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 \| NCT04919642 (AACR2024) Manual	Phase 1/2	Solid tumor FGFR1 Mutation \| FGFR2 Mutation \| FGFR3 Mutation	53	Tinengotinib 5-12mg	dsvuzvbych(ussyykzyrd) = atkpoagwmr mfqpbcemdj (rdprwujmih ) View more	Positive	05 Apr 2024
				Tinengotinib 5-12mg (prior FGFR inhibitor)	dsvuzvbych(ussyykzyrd) = mpxavrfilr mfqpbcemdj (rdprwujmih ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	30	Tinengotinib	pkjyoarqse(zceshrvame) = mkzxeevfgb nrplremqof (iwzpulgfxh ) View more	-	25 Jan 2024

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