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

FGFR positive CholangiocarcinomaAdvanced Hepatocellular CarcinomaBile Duct Neoplasms+ [16]

Inactive Indication-

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 PhasePhase 3

First Approval Date-

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

Structure/Sequence

Molecular FormulaC20H19ClN6O

InChIKeyDQFCVOOFMXEPOC-UHFFFAOYSA-N

CAS Registry2230490-29-4

Clinical Trials associated with Tinengotinib

CTR20254045

/ Active, not recruitingPhase 1

一项在健康参与者中评价多剂量伊曲康唑或利福平或艾司奥美拉唑对单剂量TT-00420药代动力学影响的单中心、开放标签、固定序列、非随机、药物相互作用的I期临床研究

[Translation] A single-center, open-label, fixed-sequence, non-randomized, drug-drug interaction phase I study evaluating the effects of multiple doses of itraconazole, rifampicin, or esomeprazole on the pharmacokinetics of a single dose of TT-00420 in healthy participants

主要目的：评价多剂量伊曲康唑或利福平或艾司奥美拉唑在健康参与者中对单剂量TT-00420药代动力学（PK）的影响次要目的：评价TT-00420与伊曲康唑或利福平或艾司奥美拉唑在健康参与者中联合给药时的安全性和耐受性

[Translation]

Primary objective: To evaluate the effects of multiple doses of itraconazole, rifampicin, or esomeprazole on the pharmacokinetics (PK) of a single dose of TT-00420 in healthy participants. Secondary objective: To evaluate the safety and tolerability of TT-00420 when co-administered with itraconazole, rifampicin, or esomeprazole in healthy participants.

Start Date03 Nov 2025

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

NCT07052253

/ Not yet recruitingPhase 2

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma.

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).

Start Date25 Jul 2025

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

[+1]

NCT06457919

/ RecruitingPhase 1/2IIT

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).

Start Date04 Jun 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

100 Clinical Results associated with Tinengotinib

100 Translational Medicine associated with Tinengotinib

100 Patents (Medical) associated with Tinengotinib

Literatures (Medical) associated with Tinengotinib

01 Apr 2025·CANCER SCIENCE

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

Article

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

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 ; Danysh, B P ; Shroff, R T ; 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 ; Li, L ; Reyes, S ; 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 ; Sootome, H ; Maurer, J ; 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 ; Hirai, H ; Vasseur, D ; 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.

01 Sep 2024·DRUGS IN R&D

Pharmacokinetics, Mass Balance, and Biotransformation of [14C]tinengotinib, A Novel Multi-target Kinase Inhibitor, in Healthy Subjects

Article

Author: Sun, Xiaofen ; Miao, Liyan ; Zhu, Yujia ; Sun, Caixia ; Fan, Jean ; Ni, Shumao ; Gu, Zheming ; Li, Lin ; Wang, Hui ; Peng, Peng ; Ma, Sheng ; Yu, Yingying ; Wu, Frank ; Yu, Zhenwen ; Zhang, Hua

BACKGROUND AND OBJECTIVE:

Tinengotinib, a novel multi-target small molecule kinase inhibitor, is currently undergoing phase II clinical trial in the USA and China. The purpose of this open-label study was to investigate the absorption, metabolism, and excretion of [¹⁴C]tinengotinib following a single oral dose in healthy subjects.

METHODS:

Six healthy male subjects received a single oral dose of [¹⁴C]tinengotinib capsules at 10 mg/100 µCi, and blood, urine, and feces samples were collected. Phenotyping experiments were further conducted to confirm the enzymes involved in its metabolism.

RESULTS:

Tinengotinib was rapidly absorbed in plasma with a time to peak drug concentration (T_max) of 1.0-4.0 h post-dose and a long terminal half-life (t_½) of 23.7 h. Blood-to-plasma radioactivity concentration ratios across timepoints ranged from 0.780 to 0.827, which indicated minimal association of radioactivity with blood cells. The mean cumulative excreted radioactivity was 99.57% of the dose, including 92.46% (68.65% as unchanged) in feces and 7.11% (0.28% as unchanged) in urine. In addition to unchanged tinengotinib, a total of 11 radioactive metabolites were identified in plasma, urine, and feces. The most abundant circulating radioactivity was the parent drug in plasma, which comprised 88.23% of the total radioactivity area under the concentration-time curve (AUC). Metabolite M410-3 was a major circulating metabolite, accounting for 5.38% of the parent drug exposure and 4.75% of the total drug-related exposure, respectively. All excreted metabolites accounted for less than 5.10% and 1.82% of the dose in feces and urine, respectively. In addition, no unique metabolites were observed in humans. Tinengotinib was metabolized mainly via CYP3A4.

CONCLUSIONS:

Overall, tinengotinib demonstrated a complete mass balance with limited renal excretion, no disproportionate blood metabolism, and slow elimination, primarily through the fecal route. The results of this study provide evidence to support the rational use of tinengotinib as a pharmacotherapeutic agent.

REGISTRATION:

ChinadrugTrials.org.cn identifier: CTR20212852.

News (Medical) associated with Tinengotinib

03 Nov 2025

·www.fiercebiotech.com

Neurocrine pens $880M deal with China\'s TransThera for red-hot immunology target

TransThera Sciences didn’t disclose the indications at which Neurocrine Biosciences will be targeting its own NLRP3 inhibitors.\n Neurocrine Biosciences has penned a deal with China’s TransThera Sciences potentially worth more than $880 million in biobucks for inhibitors aimed at a red-hot inflammation target.San Diego-based Neurocrine secured the rights to develop and commercialize preclinical NLRP3 inhibitors from TransThera outside of China. While TransThera didn’t break down the financials in its Nov. 3 release (PDF), the biotech did state that the combined upfront, development and sales milestones could reach a total of $881.5 million.The NLRP3 inflammasome helps regulate the immune system but can lead to too much inflammation if it’s dysregulated. Nonalcoholic hepatosteatosis, cardiovascular disease, diabetes and neurodegenerative conditions have all been linked to excessive NLRP3 activity, sparking interest from companies like Novo Nordisk in targeting it.Just last week, NodThera launched a phase 2 trial of its brain-penetrant NLRP3 inhibitor in combination with Novo’s obesity drug Wegovy to assess the treatment’s effect on various inflammatory and metabolic biomarkers as well as weight loss.Meanwhile, Ventyx Biosciences shared phase 2 data in June showing that its NLRP3 inhibitor—for which Sanofi has first option on the rights—was linked to improvements in Parkinson’s disease symptoms. TransThera didn’t disclose the indications at which Neurocrine will be targeting its own NLRP3 inhibitors, only stating that the licensing deal spans “multiple diseases.” The agreement also includes scope for the two companies to conduct research to “further broaden NLRP3 technology.”Neurocrine currently markets Ingrezza for a neurological syndrome called tardive dyskinesia and Crenessity for autosomal recessive disorders known as congenital adrenal hyperplasia. The biopharma’s clinical pipeline is headed up by an M4 receptor positive allosteric modulator called direclidine for schizophrenia as well as the Takeda-partnered osavampator, an AMPA potentiator being studied for stubborn depression.Nanjing-based TransThera went public on the Hong Kong stock exchange last year . The bulk of the proceeds from the IPO were earmarked for the development of the biotech’s phase 3-stage multikinase inhibitor tinengotinib in cholangiocarcinoma.

$Neurocrine pens $880M deal with China\'s TransThera for red-hot immunology target$

Phase 2License out/inIPOImmunotherapy

27 Jun 2025

·www.prnewswire.com

TransThera Publishes Translational Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Annals of Oncology

NANJING, China and GAITHERSBURG, Md., June 27, 2025 /PRNewswire/ -- TransThera Sciences Inc. ("TransThera") announced that the translational studies of tinengotinib in CCA with acquired resistance to FGFR inhibitors were published in Annals of Oncology (IF 56.7). Dr. Peng Peng, Vice President at TransThera, serves as the co-first author. CCA is an aggressive bile duct cancer often driven by FGFR2 fusion and rearrangement, which are targetable with inhibitors like pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this paper, multimodal analyses led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. Novel FGFR inhibitors should be small, high-affinity, and capable of binding to active form of FGFR. The article discloses for the first time the co-crystal structure of tinengotinib with the FGFR2 kinase domain of its unique binding mode, in addition to kinetic studies to illustrate its higher affinity compared to first-generation FGFR inhibitors, in vitro and in vivo activities against clinically acquired FGFR2 resistance mutations, as well as a case report to demonstrate its clinical efficacy. These data demonstrated that tinengotinib is a second-generation FGFR inhibitor meeting all the aforementioned criteria. Dr. Lipika Goyal, the Director of Gastrointestinal Oncology at the Stanford Cancer Center, who is the principal investigator of the study and correspondence author of the paper, stated, "The study represents a comprehensive analysis of acquired resistance to FGFR inhibitors using circulating tumor DNA, biopsy, rapid autopsy, pharmacokinetic, and in vitro and in vivo data, It represents the largest collection of primary patient data on acquired FGFR resistance, with analysis of nearly 500 clinical samples. Research in rare cancers like CCA relies on the collective efforts of numerous teams working together, and we highly appreciated the translational studies of tinengotinib by TransThera, which validated the principles of developing next-generation FGFR inhibitors highlighted in this publication. We believe this study will be a substantial contribution to the field that will advance our understanding of acquired resistance to FGFR inhibitors." "We are delighted that TransThera's discovery be part of the fundamental research in the field of overcoming FGFR refractory. Currently tinengotnib is undergoing a pivotal phase 3 study globally and we hope to bring novel treatment option to CCA patients", commented by Dr. Peng from TransThera. About Tinengotinib Tinengotinib is an internally discovered, global phase III multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation(ODD) and Fast Track Designation(FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory 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. For more information, please visit Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugFast TrackPhase 3Breakthrough Therapy

09 Dec 2024

·www.prnewswire.com

2024 ESMO Asia: TransThera announces clinical data of tinengotinib in combination with atezolizumab (PD-L1) in biliary tract carcinoma (BTC)

NANJING, China and GAITHERSBURG, Md., Dec. 9, 2024 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the " TransThera") announced the poster presentation at the 2024 European Society For Medical Oncology (ESMO) Asia Congress to discuss the clinical study of tinengotinib in combination with atezolizumab (Tecentriq®) in biliary tract carcinoma (BTC). Title: Tinengotinib (TT-00420) in Combination with Atezolizumab in Chinese Patients with Biliary Tract Carcinoma (BTC): Efficacy and Safety Results from a Phase Ib/II Study Poster number: 140P Immune-checkpoint inhibitor (ICI) combined with chemotherapy have been approved as first-line therapy for BTC. However, no standard of care has been established after first-line treatment and the survival of the patients is short, there is a huge unmet clinical need. Tinengotinib is a novel multi-kinase inhibitor. It may play a role of synergistic effect when combined with ICI. The efficacy and safety data of tinengotinib in combination with atezolizumab in Chinese BTC patients has been explored in a phase Ib/II study. Results: As of September 26, 2024, a total of 31 heavily pretreated advanced BTC patients were enrolled and treated with tinengotinib plus atezolizumab. 71.0% were priorly treated with at least one immunotherapy. Promising efficacy: A total of 20 intrahepatic cholangiocarcinoma patients were efficacy evaluable. The objective response rate (ORR) and disease control rate (DCR) were 25.0% and 80.0%, the median progression free survival (mPFS) reached 8.77 months and the 12-month overall survival (OS) rate was 70.1%. A total of 28 cholangiocarcinoma patients were efficacy evaluable. The ORR and DCR were 25.0% and 75.0%, the mPFS reached 5.72 months and the 12-month OS rate was 64.8%. All 31 BTC patients were efficacy evaluable. The ORR and DCR were 22.6% and 74.2%, the mPFS reached 4.11 months and the 12-month OS rate was 61.8%. Similar efficacy was observed regardless of prior ICI(s) therapy. Good safety and tolerability: No DLT was observed in the dose escalation phase. The combination therapy was generally well tolerated in heavily pre-treated BTC patients. These encouraging results suggest the combination therapy may have synergistic effect in treating some solid tumor such as BTC, and support the further exploration to evaluate the safety and efficacy of tinengotinib plus ICI in BTC patients who were previously treated with or without ICI therapy. About Tinengotinib Tinengotinib is an internally discovered, global phase III multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by EMA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory 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. For more information, please visit Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultOrphan DrugFast TrackPhase 3Immunotherapy

100 Deals associated with Tinengotinib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
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
FGFR positive Cholangiocarcinoma	Phase 3	Portugal	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Spain	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


NCT03654547 (ESMO2025)	Phase 1/2	Advanced Bile Duct Carcinoma FGFR2-altered	109	Tinengotinib	gmtysjajro(nelspgbqkq) = qnaawpxcpr vqwdgqzicj (ywzgimxzzq ) View more	Positive	17 Oct 2025
				Tinengotinib (FGFR2-altered)	weodvvnegi(oegrexzlhv) = lduvwnqhne mxgzuomysi (hqetfombnz, 9.43 - 19.48) View more
NEWS Manual	Not Applicable	Bile Duct Neoplasms	43	Tinengotinib	mgxtwkmwyf(ezkkmilxwf) = dhymznzcde rqrixkhmdn (rbpjbgiryz ) 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	vbtlymywbt(eazwnwrnsm) = neqlmobqdm eeoixipxsh (pgunhsicjb ) 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	zemhwnjyss(nrzytkzvcw) = No notable difference in AUC was observed in QD vs. BID schedules lrbhczlpsp (eexptybavf ) 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	lvdoidwonu(ygpnardjsb) = suspected grade 3 TSH increase csuvnoaxcu (lprszjqiiu ) 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))	voknndsyfq(kpbcdrphnv) = jcynjpmzwh xeesgbddbd (ofqvpbgqxo, 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)	voknndsyfq(kpbcdrphnv) = mzaodibgcf xeesgbddbd (ofqvpbgqxo, 9.6 - NR)
NCT05253053 (TT-00420, ESMO_ASIA2024) Manual	Phase 1/2	Biliary Tract Neoplasms	31	Tinengotinib + Atezolizumab	ziymqmfjdx(faioaxpabo) = rzhgpcziqw vbcobasgps (cxvwryfnir ) View more	Positive	07 Dec 2024
				Tinengotinib + Atezolizumab (cholangiocarcinoma)	ziymqmfjdx(faioaxpabo) = amjimrolqr vbcobasgps (cxvwryfnir ) View more
NCT05253053 \| NCT04742959 \| NCT04919642 \| NCT03654547 (AACR2024) Manual	Phase 1/2	Solid tumor FGFR1 Mutation \| FGFR2 Mutation \| FGFR3 Mutation	53	Tinengotinib 5-12mg	zyiafdkbss(cyaxievion) = enozqpicvb txvlkxyrat (vukqiuaxlv ) View more	Positive	05 Apr 2024
				Tinengotinib 5-12mg (prior FGFR inhibitor)	zyiafdkbss(cyaxievion) = hvgahhorhz txvlkxyrat (vukqiuaxlv ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	30	Tinengotinib	ajuxpvylwc(qxboxevdjg) = pjvqzuvmiy navkclgdaq (vdzsrkbjfp ) View more	-	25 Jan 2024
NCT04919642 (ASCO_GI2024) Manual	Phase 2	Metastatic Cholangiocarcinoma FGFR Mutation	48	Tinengotinib 10 mg (FGFR2 fusion/rearrangement)	wmxlfuhqjh(drlgvmzrdc) = bgzrahqpjk hidbghaays (eighouffug ) View more	Positive	18 Jan 2024
				Tinengotinib 10 mg (primary progression on previous FGFR inhibitor)	tagljdaxco(zuixfihlzp) = aismemnejw lhcvvkrveb (wfswlztaba )

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