FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsCongenital DisordersDigestive System Disorders+ [8]

Active Indication

Advanced Bile Duct CarcinomaChromosome 8p11 myeloproliferative syndromeBile Duct Neoplasms+ [23]

Inactive Indication

Advanced cancerAdvanced Lung Non-Small Cell CarcinomaChromosomal translocation+ [15]

Originator Organization

Incyte Corp.

Active Organization

Incyte Corp.

Innovent Biologics (Suzhou) Co. Ltd.Incyte Biosciences Distribution BV

+ [4]

Inactive Organization-

License Organization

Incyte Corp.Specialised Therapeutics Asia Pte Ltd.

Knight Therapeutics, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (17 Apr 2020),

FGFR2 positive Intrahepatic Cholangiocarcinoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Molecular FormulaC24H27F2N5O4

InChIKeyHCDMJFOHIXMBOV-UHFFFAOYSA-N

CAS Registry1513857-77-6

Clinical Trials associated with Pemigatinib

NCT07434843

/ RecruitingPhase 2IIT

PEMIGIST: Phase 2 Study of Pemigatinib (INCB054828) in the Treatment of Patients With Advanced SDH-deficient Gastrointestinal Stromal Tumor (GIST)

The purpose of this study is to determine how effective the drug pemigatinib is as a treatment option for advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors(GIST). This study will also assess the side effects associated with pemigatinib and evaluate its tolerability.
The name of the study drug involved in this study is:
• Pemigatinib (INCB054828)

Start Date01 Apr 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT06728410

/ RecruitingPhase 2IIT

A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.

Start Date27 Jan 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

NCT06300528

/ RecruitingPhase 2IIT

PERFORM: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas

The purpose of this clinical trial is to learn if the study drug pemigatinib is effective in treating patients with relapsed or refractory B-cell non-Hodgkin lymphomas.

Start Date03 Oct 2025

Sponsor / Collaborator

University of Utah

[+1]

100 Clinical Results associated with Pemigatinib

100 Translational Medicine associated with Pemigatinib

100 Patents (Medical) associated with Pemigatinib

289

Literatures (Medical) associated with Pemigatinib

01 Mar 2026·BMJ Open Ophthalmology

Impact of anticancer drugs on human Tenon’s fibroblast proliferation: implications for glaucoma surgery

Article

Author: Marengo, Barbara ; Montalto, Giulia ; Pronzato, Maria A ; Passalacqua, Mario ; Vernazza, Stefania ; Villa, Viviana ; Cutolo, Carlo Alberto ; Ricciarelli, Roberta ; Iester, Michele

Objective:

Elevated intraocular pressure (IOP) is a major risk factor for glaucoma and the primary target of current therapies. When IOP-lowering drugs are insufficient, surgical intervention may be required; however, conjunctival and subconjunctival scarring often limits long-term success. Although intraoperative and postoperative antimetabolite treatments help preserve surgical outcomes, they are associated with ocular side effects. This study investigated the effects of selected anticancer drugs on the proliferation of human Tenon’s fibroblasts (HTFs), key mediators of postoperative scarring.

Methods and analysis:

Primary HTFs were isolated from explants obtained during glaucoma surgery and characterised by immunofluorescence. The cytotoxic effects of candidate drugs were assessed using the MTT and LDH assays, while HTF migration and proliferation were evaluated by wound-healing assays. Additional cytotoxicity testing was performed on primary human trabecular meshwork cells (HTMCs) to assess ocular safety.

Results:

Under the experimental conditions used, HTF proliferation, rather than migration, was the main driver of wound closure. Among the drugs tested, pemigatinib and sorafenib significantly slowed wound closure. Pemigatinib showed no cytotoxicity in either HTFs or HTMCs, whereas sorafenib induced a moderate (28%) cytotoxic effect in HTMCs.

Conclusions:

Pemigatinib and sorafenib, two Food and Drug Administration-approved anticancer agents, effectively reduced HTF proliferation, with pemigatinib showing a more favourable safety profile. These findings identify selective fibroblast growth factor receptor (FGFR) inhibition as a promising strategy for modulating postoperative fibrosis and support further preclinical studies to evaluate the safety and efficacy of FGFR inhibitors as potential adjuncts in glaucoma surgery.

01 Mar 2026·Journal of Drugs in Dermatology

Management of Nail Toxicities From Fibroblast Growth Factor Receptor Inhibitors

Review

Author: Fan, Xiying ; Smith, Janellen ; Patel, Aneri Bhargav

BACKGROUND:

Alterations in fibroblast growth factor receptor (FGFR) signaling are present in many malignancies, including urothelial carcinoma, cholangiocarcinoma, and gastrointestinal cancers, and FGFR inhibitors (FGFRi) play an increasing role in the treatment of these malignancies. Nail toxicities, such as onycholysis, paronychia, and nail fragility are an important part of the adverse effect profile of FGFRi that remain underrecognized and poorly characterized.

METHODS:

We conducted a systematic literature review using PubMed and Google through March 2025, including case reports, trials, and retrospective studies reporting FGFRi-related nail disorders. Search terms included individual FGFRi (e.g., erdafitinib, pemigatinib, futibatinib) and nail-related adverse events. Data on incidence, severity (CTCAE v5.0), onset, management, and treatment impact were extracted. Statistical analyses included the Wilcoxon and Chi-square tests.

RESULTS:

Twenty-three studies with 1,561 patients were analyzed. Out of these, 540 patients experienced nail toxicity. Erdafitinib had the highest nail toxicity rate (43.3%) and derazantinib the lowest (5.3%). Grade 1–2 events were most common; Grade 3 events prompted dose reduction in three patients out of 540, though no treatment discontinuations were reported. Common management strategies included antiseptic soaks, topical steroids, oral antibiotics, and protective nail care practices.

DISCUSSION/CONCLUSION:

The incidence of FGFRi-associated nail toxicities varies by agent and can affect quality of life and treatment adherence. The pathogenesis remains unclear, and no predictive biomarkers exist. Further research into optimized management and preventative strategies is needed. Early recognition and proactive multidisciplinary management are essential to minimizing complications and maintaining oncologic treatment continuity. .

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 ; Fonkoua, Lionel Kankeu ; Pelster, Meredith ; Wang, Hui ; Li, Daneng ; Kingsley, Edwin ; Fan, Jean ; Liao, Chih-Yi ; Hennessy, Katie ; Deming, Dustin ; Mahipal, Amit ; 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.

182

News (Medical) associated with Pemigatinib

16 Apr 2026

·allsci.com

Partner Therapeutics seeking third indication for Bizengri in NRG1 fusion-positive cholangiocarcinoma

Partner Therapeutics submitted a supplemental Biologics License Application (sBLA) to the US FDA on April 14, 2026 for Bizengri (zenocutuzumab-zbco), seeking approval for adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion. The filing marks the first regulatory submission for Bizengri in this bile duct malignancy with the aim of adding a third indication to the molecule’s existing accelerated approvals in NRG1 fusion-positive non-small cell lung cancer and pancreatic adenocarcinoma. The sBLA seeks approval without restriction to a specific line of therapy, the company said. The filing is supported by data from the eNRGy study, a basket trial evaluating zenocutuzumab-zbco across NRG1 fusion-positive solid tumors. No priority review or accelerated pathway designation was disclosed in the announcement, and the company did not provide a projected PDUFA date. Bizengri’s cholangiocarcinoma data The cholangiocarcinoma cohort of the eNRGy study generated an overall response rate of 36.8% (95% CI: 16.3, 61.6%) and a median duration of response of 12.9 months, as assessed by blinded independent central review. No patients in that cohort discontinued therapy due to adverse events, the company said. The mechanism underlying the filing differs from all currently approved CCA therapies: zenocutuzumab-zbco is a bispecific antibody that simultaneously blocks HER2/HER3 heterodimerization and NRG1 fusion interactions with HER3, disrupting downstream signaling driven by NRG1 chimeric ligands rather than the chimeric receptors targeted by FGFR inhibitors such as pemigatinib and futibatinib. NRG1 fusions are estimated to occur in fewer than 2% of cholangiocarcinoma cases, and the source material states that no approved therapies currently target this molecular subgroup in the disease. The rarity of the alteration creates a diagnostic challenge: unlike NTRK, RET, or FGFR fusions, NRG1 fusions produce chimeric ligands that are frequently missed by DNA-only next-generation sequencing panels and require tissue-based RNA testing for reliable detection. Partner Therapeutics noted this in its announcement, with Chief Development Officer Pritesh Gandhi stating that RNA testing is essential to ensure patients with NRG1-driven tumors are identified. NCCN guidelines The filing arrives alongside a notable guideline development. The National Comprehensive Cancer Network added zenocutuzumab-zbco to its oncology clinical practice guidelines for biliary tract cancers as a Category 2A subsequent-line therapy and as a Category 2B recommendation for front-line treatment of NRG1 fusion-positive cholangiocarcinoma — the latter positioning preceding any formal regulatory approval for the indication. Dr. James Cleary of Dana-Farber Cancer Institute, commenting in the release, described NRG1 gene fusions as an actionable biomarker in this disease and said the eNRGy data suggest targeted inhibition with zenocutuzumab may represent a meaningful treatment approach. The cholangiocarcinoma treatment landscape has undergone substantial change since 2020, when pemigatinib became the first targeted therapy approved in the disease. Ivosidenib followed in 2021 for IDH1-mutant CCA, futibatinib in 2022 for FGFR2 fusion-positive intrahepatic disease, and durvalumab in combination with gemcitabine and cisplatin was approved the same year for first-line biliary tract cancer regardless of biomarker status. Pembrolizumab combined with gemcitabine and cisplatin received approval in 2023 for the same unselected population. Despite this expansion, the molecular subgroup defined by NRG1 fusions has remained without a specifically labeled therapy, and the eNRGy data represent the primary clinical evidence base for this population in CCA. The sBLA adds to a field where accelerated approval pathways have played a central role, and where the durability of those approvals has varied. Infigratinib, an FGFR1–3 inhibitor that received accelerated approval in 2021 for FGFR2 fusion-positive CCA, was voluntarily withdrawn in 2024 after a confirmatory trial failed to verify clinical benefit — a precedent that underscores the regulatory risk associated with response-rate-based submissions in this disease. The eNRGy cholangiocarcinoma cohort was small, as is typical for trials enrolling rare fusion-defined populations, and the 95% confidence interval for the reported ORR is correspondingly wide. Bizengri’s existing accelerated approvals in NSCLC and pancreatic adenocarcinoma were also granted based on overall response rate and duration of response, with continued approval in those indications contingent on confirmatory trial data. The cholangiocarcinoma sBLA follows the same evidentiary model. Partner Therapeutics holds exclusive US rights to develop and commercialize zenocutuzumab-zbco under an agreement with Merus B.V., a wholly owned subsidiary of Genmab. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

24 Mar 2026

·www.einpresswire.com

Gateway Celebrity Fight Night Delivers an Unforgettable Evening Directly Funding Early-Phase Cancer Research

Bryan Adams, David Foster, and Others Unite for Fundraiser, with 100% of Money Raised Directly Funding Early-Phase Cancer Research Gateway for Cancer Research is at the cutting edge of early-phase discovery, where bold ideas are transformed into life-changing possibilities.” — Dr. Stacie J. Stephenson, Vice-Chair Gateway for Cancer Research PHOENIX, AZ, UNITED STATES, March 24, 2026 / EINPresswire.com / -- Dr. Stacie J. Stephenson and Richard J Stephenson, Chairman and Vice-Chair of Gateway for Cancer Research , a nonprofit 501c(3) organization committed to funding innovative Phase I and Phase II cancer clinical trials, hosted Arizona’s premiere fundraising event of the season, Gateway Celebrity Fight Night , on Saturday, March 21st at the Fairmont Scottsdale Princess in Scottsdale, Arizona. The evening showcased the vibrant energy and dedication of the community coming together for a shared mission: to champion groundbreaking cancer research and highlight the importance of early-phase clinical trials in transforming patient care. This year’s Gateway Celebrity Fight Night drew entertainers, musicians, philanthropists, and leading medical experts to raise critical funds for early-phase cancer clinical trials, an area often overlooked and underfunded, yet essential to advancing the most promising new cancer drugs and therapies. Bryan Adams, Grammy Award winning singer and global rock icon, headlined the event with a dynamic private rock concert and featured renowned 16-time Grammy Award winning producer, David Foster, whose longstanding role as Musical Director continues to shape the event’s signature sound. The evening was emceed by cancer survivor, actor, and Broadway star Erich Bergen (Love Story, Madam Secretary), whose humor charmed and energized the room, plus powerhouse R&B vocalist Sheléa, and captivating jazz singer Brenna Whitaker, each delivering unforgettable performances that elevated the night’s celebration. Guests were also introduced to the powerful story of James “Chris” Kirk, a patient impacted by a Gateway-funded clinical trial after being diagnosed with stage four pancreatic cancer and a rare FGFR mutation found in only 1% of patients. Chris is under the care of Dr. Sameek Roychowdhury, a renowned physician at The Ohio State University Comprehensive Cancer Center, and Head of Gateway for Cancer Research’s Scientific Peer Review. Dr. Roychowdhury is leading an innovative Phase II study that uses telemedicine to deliver pemigatinib to pancreatic cancer patients with FGFR gene alterations. This approach allows patients like Chris to receive groundbreaking treatment from home, with medications shipped and labs handled locally. Early results show promising patient outcomes, giving Chris a renewed sense of HOPE and more time with his family. “Gateway for Cancer Research is at the cutting edge of early-phase discovery, where bold ideas are transformed into life-changing possibilities,” shared the evening’s host, Dr. Stacie J. Stephenson, integrative health expert and bestselling author. “Every breakthrough begins with courageous patients, visionary researchers, and a community of supporters who believe in what’s possible. Together, we are accelerating progress and bringing new hope to those who need it most.” “Gateway for Cancer Research continues to demonstrate what is possible when purpose and generosity come together,” said Gateway’s Founder, Richard J Stephenson. “We are deeply grateful for the extraordinary support of our donors and partners, whose commitment allows us to fund innovative research that has the potential to save lives.” The black-tie event featured a cocktail reception, elegant dinner and an exciting live auction including a one-of-a-kind sapphire and diamond ring, plus a brand-new 2026 Toyota Land Cruiser donated by Valley Toyota Dealers . For more information about Gateway for Cancer Research, visit https://www.gatewaycr.org. *** About Gateway for Cancer Research Gateway for Cancer Research℠ is a nonprofit 501c(3) organization committed to finding, funding and furthering innovative cancer research that helps cancer patients feel better and live longer as we work to end cancer as we know it. Thanks to generous underwriting by Dr. Stacie J. and Mr. Richard J Stephenson, 100% of every donation directly funds Phase I and Phase II cancer clinical trials at leading research institutions around the world. Since its inception in 1991, Gateway has invested more than $126 million to advance 249 cancer clinical trials. These studies have delivered HOPE and healing to more than 10,000 patients, altered the standard of care at some of the world's most trusted health care institutions, and contributed to new FDA-approved cancer treatments. Get involved today by visiting GatewayCR.org, like us on Facebook at GatewayCancerResearch and follow us on Instagram at @GatewayforCR, #GatewayCelebrityFightNight #CelebrityFightNight #BeAGateway #GatewayForCancerResearch #KnockOutCancer Jennifer McIntosh Krupp Agency +1 480-202-7112 email us here Visit us on social media: Instagram Facebook X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2

05 Dec 2025

·www.prnewswire.com

TransThera Publishes Clinical Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Lancet

NANJING, China and GAITHERSBURG, Md., Dec. 4, 2025 /PRNewswire/ -- TransThera Sciences Inc. ("TransThera") announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6). Cholangiocarcinoma (CCA) is an aggressive malignancy of the bile ducts, frequently driven by FGFR2 fusions-genomic alterations that are targetable by FGFR inhibitors such as pemigatinib and futibatinib. However, resistance to these agents commonly arises due to secondary FGFR2 mutations. In a multicenter, open-label Phase 2 trial (NCT04919642), patients with FGFR2 fusion-positive CCA who had either primary resistance or developed acquired resistance to prior FGFR inhibitor (FGFRi) therapy were enrolled, along with patients harboring other FGFR alterations or FGFR wiled-type tumors. Tinengotinib demonstrated clinical activity in patients with FGFR2 fusion-positive CCA with acquired FGFRi resistance, as well as in those with other FGFR-altered subtypes. Dr. Milind Javle of The University of Texas MD Anderson Cancer Center, corresponding author of the publication, stated: "We currently have two FDA-approved therapies targeting FGFR2 fusions in CCA. But resistance remains a major clinical challenge. As such, next generation FGFR inhibitors capable of overcoming resistance are urgently needed. Tinengotinib, as a multi-kinase FGFR inhibitor, is designed to inhibit both FGFR and compensatory pathways contributing to resistance. In this phase 2 study, tinengotinib demonstrated durable responses and meaningful clinical benefit. These promising results provide a strong rationale to proceed with a Phase 3 registration study". Dr. Jean Fan, Chief Medical Officer of TransThera, also commented: "We are very pleased that the clinical trial results have gained peer recognition and were published in such a prestigious journal. This study provides important insights into treatment strategies for patients with FGFR-altered, chemotherapy- and FGFR inhibitor–refractory or relapsed CCA, including the comparison of tinengotinib versus physician's choice. We are committed to advancing global enrollment and delivering new treatment options for patients with metastatic cholangiocarcinoma." Disclaimer: This article serves as a press release by TransThera to disclose the company's latest developments. It is not intended as a product promotion advertisement and does not constitute the company's or investment advice. About Tinengotinib Tinengotinib is an internally discovered, registrational clinical stage, 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 the National Medical Products Administration (NMPA) in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA). It was also approved for inclusion in the Priority Review and Approval Procedure by the NMPA for the treatment of CCA. 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 SOURCE TransThera Sciences (Nanjing) Inc. 21% more press release views with Request a Demo

Orphan DrugFast TrackClinical ResultPhase 2Breakthrough Therapy

100 Deals associated with Pemigatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11417	Pemigatinib	L01XE	DB15102

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Bile Duct Carcinoma	South Korea	Handok, Inc.	25 Apr 2023
Chromosome 8p11 myeloproliferative syndrome	United States	Incyte Corp.	26 Aug 2022
Bile Duct Neoplasms	Canada	Incyte Corp.	17 Sep 2021
Locally Advanced Cholangiocarcinoma	European Union	Incyte Biosciences Distribution BV	26 Mar 2021
Locally Advanced Cholangiocarcinoma	Iceland	Incyte Biosciences Distribution BV	26 Mar 2021
Locally Advanced Cholangiocarcinoma	Liechtenstein	Incyte Biosciences Distribution BV	26 Mar 2021
Locally Advanced Cholangiocarcinoma	Norway	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	European Union	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	Iceland	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	Liechtenstein	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	Norway	Incyte Biosciences Distribution BV	26 Mar 2021
FGFR2 fusion or rearranged Cholangiocarcinoma	Japan	Incyte Corp.	23 Mar 2021
FGFR2 positive Intrahepatic Cholangiocarcinoma	United States	Incyte Corp.	17 Apr 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	United States	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	China	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Japan	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Austria	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Belgium	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Canada	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Denmark	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Finland	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	France	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	Germany	Incyte Corp.	03 Jun 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_TAT2026	Not Applicable	FGFR2 positive Intrahepatic Cholangiocarcinoma Second line FGFR2 fusion/rearrangement-positive	54	Pemigatinib (TP53 mutations)	gqwpdvsxqo(aspumozcoi) = cspjljkxud upovsnaohk (pehmsjyfpk ) View more	Negative	16 Mar 2026
				Pemigatinib (TP53 wild-type)	gqwpdvsxqo(aspumozcoi) = fkpvzslhdy upovsnaohk (pehmsjyfpk ) View more
ESMO_SRC2026	Not Applicable	Central Nervous System Neoplasms	9	infigratinib	dxqxyhvukb(repldvvubl) = Toxicities included fatigue, visual changes, hyperphosphatemia and stomatitis. Two patients required dose reductions and four required discontinuation due to toxicity (visual changes - 1, hyperphosphatemia - 1 and fatigue - 2) igjgiikyoz (eldwxemueh )	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	SDH-deficient Gastrointestinal Stromal Tumors	19	imatinib	nqebhnizti(cuwvmcrbdr) = zozdrxufxv kcsaoevosf (flleuzjkhy, 50.7 - NR)	Positive	09 Mar 2026
				sunitinib	ptudzvevof(skaxmyfped) = paiciqpwuu wggsamzckr (lqljtrypfd )
NCT05267106 (FIGHT-209, CTgov)	Phase 2	Glioblastoma Multiforme \| Glioblastoma, IDH-Wildtype \| Glioblastoma ... View more	83	pemigatinib (Recurrent Glioblastoma)	jhyytgztlh = qhvgwswebm bkrpqngsbv (jfictfpxfk, nilvkaaukv - nrvgvacwwa) View more	-	30 Dec 2025
				pemigatinib (Recurrent Non-glioblastoma CNS Tumors)	giwibjwtjj = ovzdboocoz defzpeudpg (fmsfrebnqz, yydnjimwst - nanhkiuiiz) View more
NCT03011372 (FIGHT-203, CTgov)	Phase 2	Myeloid Tumor \| Hematologic Neoplasms \| Myeloproliferative Disorders	47	Pemigatinib	rdenxikegu = hiunreqdtt pzsqtzfyol (otoagnknmh, cxofckpkcq - ogzdtxeomq) View more	-	18 Nov 2025
JPRN-UMIN000053840 (JON2303 B, ESMO_GI2025)	Phase 2	FGFR2 fusion gene \| FGFR2 gene rearrangement \| BAP1 alteration ... View more	71	Pemigatinib	lnywqrbzwe(qrogglnnoi) = awiexwqwbb fgsqkxbiei (umjnfxfhhy ) View more	Positive	03 Jul 2025
NCT04096417 (Pubmed \| Oncologist)	Phase 2	Colorectal Cancer	-	Pemigatinib	bwdyokvzij(inqymauapv) = grade 3 or higher AE, 42.9% dycpfntydv (plxsgpestk ) View more	-	04 Jun 2025
NCT05267106 (FIGHT-209, ASCO2025)	Phase 2	Glioblastoma \| Glioma FGFR1-3 fusion/rearrangement \| FGFR1 mutation	-	Pemigatinib 13.5 mg	yfopeufgaa(jmlgbvtqiu) = rajqickpgn rdlhkgzawl (noltfhqnfo ) View more	Negative	30 May 2025
				Placebo	yfopeufgaa(jmlgbvtqiu) = dazvidoxca rdlhkgzawl (noltfhqnfo ) View more
NCT04294277 (PEGASUS, CTgov)	Phase 2	Urothelial Carcinoma of the Urinary Bladder	2	Pemigatinib	bkpzckslmg(knobgsydun) = xalbmznhzs zzrbtgcccq (pzwwzrhvuc, wzscrflqbb - zxuxbymhmr) View more	-	18 Apr 2025
ESMO_TAT2025	Not Applicable	Biliary Tract Neoplasms First line molecular alterations	666	Targeted Therapy	vfbmgjureh(fcdebjlqhz) = jvoqpfxjqa afujvoyjbm (hxtoxnbvyt, 13.9 - 29.1) View more	Positive	03 Mar 2025
				Chemotherapy	vfbmgjureh(fcdebjlqhz) = zrccyfvqtu afujvoyjbm (hxtoxnbvyt )

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis