pharma · Non-small Cell Lung Cancer · Epilepsy
Eisai Co.,
Eisai is a pharma organization headquartered in Tokyo, JP. Primary therapeutic focus areas include Non-small Cell Lung Cancer, Epilepsy, colorectal cancer, melanoma, hepatocellular carcinoma, Amyotrophic Lateral Sclerosi
Phase 2 · small molecule · Cholangiocarcinoma
E7090 is a fibroblast growth factor receptor 1 (FGFR1) inhibitor being developed by Eisai Co., Ltd. as a small-molecule therapeutic for cholangiocarcinoma. The program is currently in Phase 2 development, with the most recent milestone dated March 2, 2026. FGFR1 inhibition represents a targeted approach to address dysr
Internal code E7090-J000-201
E7090 is a fibroblast growth factor receptor 1 (FGFR1) inhibitor being developed by Eisai Co., Ltd. as a small-molecule therapeutic for cholangiocarcinoma. The program is currently in Phase 2 development, with the most recent milestone dated March 2, 2026. FGFR1 inhibition represents a targeted approach to address dysregulated fibroblast growth factor signaling implicated in cholangiocarcinoma pathogenesis. Eisai is pursuing this indication independently without disclosed partnership arrangements. The clinical development is supported by at least one active clinical trial (NCT04238715) registered in China. The Phase 2 status indicates the program has demonstrated sufficient preliminary efficacy and safety to warrant expansion beyond early-stage evaluation, though pivotal Phase 3 data have not yet been disclosed. The competitive landscape for cholangiocarcinoma therapeutics is robust, with multiple FGFR inhibitors and other targeted agents in Phase 2–3 development across the industry.
Cholangiocarcinoma represents a significant unmet medical need due to its aggressive biology, limited treatment options, and poor prognosis. The disease accounts for a small but clinically important subset of biliary tract malignancies, with incidence varying geographically and rising in certain regions. Conventional chemotherapy regimens offer modest survival benefit, creating opportunity for targeted therapies that address specific molecular drivers. FGFR alterations, including fusions and mutations, occur in a meaningful subset of cholangiocarcinoma cases, making FGFR-directed inhibition a rational therapeutic strategy. E7090's advancement to Phase 2 positions it within a crowded but therapeutically important competitive space. The commercial significance is moderate to substantial, depending on the prevalence of FGFR-driven disease and the drug's efficacy and safety profile relative to competitors. Eisai's focus on this indication aligns with oncology market priorities and addresses a patient population with limited alternatives. Success could establish E7090 as a key option in the cholangiocarcinoma treatment armamentarium, particularly for FGFR-altered tumors.
Drug Class: Targeted tyrosine kinase inhibitor (TKI)
Mechanism of Action: Fibroblast growth factor receptor 1 (FGFR1) inhibitor
Molecular Modality: Small molecule
Target: FGFR1 (fibroblast growth factor receptor 1)
Route of Administration: Not yet disclosed
Therapeutic Class: Not yet disclosed
Related Therapies: Other FGFR inhibitors in development for cholangiocarcinoma include BGJ398 (BridgeBio), pemigatinib and INCB 54828-302 (Incyte), TAS-120 (Taiho), and compounds from AstraZeneca and others. Broader competitive approaches include immunotherapy (e.g., TREMELIMUMAB) and other targeted mechanisms.
First Approval: Not yet disclosed; program remains in clinical development
Patent Status: Not yet disclosed
Also known as: bile duct cancer, intrahepatic bile duct cancer (cholangiocarcinoma), CC, CCA, Cholangiocar.- intra/extrahepatic, Cholangiocellular carcinoma
Prevalence: Point prevalence: 1-9 / 100 000 (Worldwide) — source: Orphanet, validated.
A carcinoma that arises from the intrahepatic biliary tree (intrahepatic cholangiocarcinoma) or from the junction, or adjacent to the junction, of the right and left hepatic ducts (hilar cholangiocarcinoma). Grossly, the malignant lesions are solid, nodular, and grayish. Morphologically, the vast majority of cases are adenocarcinomas. Signs and symptoms include malaise, weight loss, right upper quadrant abdominal pain, and night sweats. Early detection is difficult and the prognosis is generally poor.
ClinicalTrials.gov lists 92 registered studies for Bile Duct Cancer (AACT aggregate).
Phase breakdown: NA (44), PHASE2 (21), PHASE1 (13), PHASE1/PHASE2 (4), PHASE4 (4), PHASE2/PHASE3 (3), PHASE3 (3)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0019087), Orphanet — cholangiocarcinoma, NCT00183846, NCT00280709, NCT00356161, NCT00579865, NCT00624182, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 2 ongoing
E7090 Phase 2 clinical trial (NCT04238715) active in China for cholangiocarcinoma.
Latest milestone
Most recent disclosed milestone date; specific milestone summary not yet disclosed.
E7090 operates within a highly competitive cholangiocarcinoma therapeutic landscape dominated by FGFR-directed small molecules. Key competitors include BGJ398 (BridgeBio Oncology Therapeutics) and pemigatinib/INCB 54828-302 (Incyte), both in Phase 3 development. AstraZeneca's D7025C00001, Taiho's TAS-120, and The George Institute's Tibsovo are also advancing in Phase 3 trials. Additional Phase 3 programs include PRODIGE 118-PEHRICCA (CERO Therapeutics) and investigational agents from Disc Medicine and others. E7090's Phase 2 status places it behind several competitors in clinical advancement, suggesting a later market entry timeline if development proceeds successfully. The competitive field reflects strong industry interest in FGFR inhibition for cholangiocarcinoma, indicating validation of the target but also suggesting potential market saturation. Differentiation will likely depend on E7090's efficacy, safety profile, selectivity, and pharmacokinetic properties relative to more advanced competitors. Phase 2 phase-mate programs (TREMELIMUMAB, TAS-120, CLEAN-DUCT) suggest exploration of combination strategies and alternative mechanisms may also influence competitive positioning.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| [18F]-AlF-FAPI-74 for Cholangiocarcinoma | Disc Medicine | small_molecule | phase_3 |
| BGJ398 | BridgeBio Oncology Therapeutics | small_molecule | phase_3 |
| PRODIGE 118-PEHRICCA | CERO THERAPEUTICS HOLDINGS, INC. | small_molecule | phase_3 |
| D7025C00001 | AstraZeneca AB | small_molecule | phase_3 |
| Tibsovo 250 mg film-coated tablets | The George Institute | small_molecule | phase_3 |
| INCB 54828-302 | Incyte | small_molecule | phase_3 |
| Pemigatinib | Incyte | small_molecule | phase_3 |
| TREMELIMUMAB for locally advanced cholangiocarcinoma | Fondazione Telethon ETS | small_molecule | phase_2 |
| - | Ningbo Cancer Hospital | small_molecule | phase_2 |
| TAS-120 | Taiho Pharma Netherlands B.V. | small_molecule | phase_2 |
| CLEAN-DUCT | The George Institute | small_molecule | phase_2 |
| INFIGRATINIB PHOSPHATE | — | Fibroblast growth factor receptor inhibitor | Approved |
| FUTIBATINIB | — | Fibroblast growth factor receptor inhibitor | Approved |
| TORIPALIMAB | — | Programmed cell death protein 1 antagonist | Phase 3 |
| TISLELIZUMAB | — | Programmed cell death protein 1 inhibitor | Phase 3 |
| TEGAFUR | — | Thymidylate synthase inhibitor | Phase 3 |
| PACLITAXEL | — | Tubulin inhibitor | Phase 3 |
| LENVATINIB MESYLATE | — | Vascular endothelial growth factor receptor inhibitor | Phase 3 |
| LENVATINIB | — | Vascular endothelial growth factor receptor inhibitor | Phase 3 |
| IVOSIDENIB | — | Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
China (NMPA): E7090 is currently in clinical trials in China under the regulatory framework overseen by the National Medical Products Administration (NMPA). The active trial NCT04238715 indicates ongoing clinical evaluation.
United States (FDA): Regulatory status in the United States not yet disclosed.
Europe (EMA): Regulatory status in Europe not yet disclosed.
Japan (PMDA): Regulatory status in Japan not yet disclosed.
Summary: E7090 remains in clinical development phase globally. No regulatory filings, breakthrough designations, or approvals have been disclosed. The program's advancement will depend on Phase 2 efficacy and safety outcomes and subsequent regulatory interactions with major health authorities.
E7090 is a fibroblast growth factor receptor 1 (FGFR1) inhibitor being developed by Eisai Co., Ltd. for the treatment of cholangiocarcinoma, a rare biliary tract malignancy.
E7090 inhibits fibroblast growth factor receptor 1 (FGFR1), a protein involved in cell growth and survival. By blocking FGFR1 signaling, the drug aims to suppress tumor cell proliferation in cholangiocarcinoma cases driven by FGFR alterations.
E7090 is currently in Phase 2 clinical development. The most recent milestone was disclosed on March 2, 2026, indicating ongoing clinical evaluation.
E7090 is being developed by Eisai Co., Ltd., a Japanese pharmaceutical company. No partner or co-developer has been disclosed.
E7090 is being evaluated in clinical trial NCT04238715, a Phase 2 study in patients with cholangiocarcinoma. The trial is registered in China and is currently active.
No, E7090 is not approved by the FDA. The drug remains in Phase 2 clinical development and has not submitted a regulatory application.
The route of administration for E7090 has not yet been disclosed.
E7090 is a fibroblast growth factor receptor 1 (FGFR1) inhibitor. It works by blocking FGFR1 signaling, which is implicated in cholangiocarcinoma pathogenesis.
E7090 competes with multiple FGFR inhibitors in development, including BGJ398 (BridgeBio), pemigatinib (Incyte), TAS-120 (Taiho), and compounds from AstraZeneca, The George Institute, and others. Most competitors are in Phase 3 development, ahead of E7090.
E7090 is being developed for patients with cholangiocarcinoma, a rare biliary tract cancer. The specific patient population (e.g., FGFR-altered tumors, treatment-naïve vs. pretreated) has not yet been fully disclosed.
The expected approval timeline for E7090 has not been disclosed. Given its Phase 2 status and the competitive landscape, approval is unlikely before 2027–2029 at the earliest, assuming successful Phase 3 progression.
Cholangiocarcinoma has limited treatment options and poor prognosis. Conventional chemotherapy offers modest survival benefit, creating significant opportunity for targeted therapies that address specific molecular drivers such as FGFR alterations.
E7090 is a small-molecule drug, specifically a tyrosine kinase inhibitor targeting FGFR1.
E7090 targets fibroblast growth factor receptor 1 (FGFR1), a protein involved in cell growth and proliferation.
Special regulatory designations (e.g., Breakthrough Therapy, Orphan Drug) for E7090 have not been disclosed.
E7090's commercial potential depends on its efficacy, safety, and market penetration relative to competitors. Cholangiocarcinoma is a smaller oncology market, but FGFR-driven disease enrichment and limited alternatives could support a focused commercial strategy.
E7090 → Drug → Target → Indication → Company → Trials → Competitors
Development Strategy: Eisai's pursuit of E7090 in cholangiocarcinoma reflects confidence in FGFR1 as a validated target in this indication. The Phase 2 status and recent milestone (March 2026) suggest active enrollment and data generation, though the program lags several competitors in clinical advancement.
Competitive Implications: E7090 enters a crowded FGFR inhibitor space with multiple Phase 3 programs approaching potential approval. Differentiation will be critical; success likely requires superior efficacy, tolerability, or pharmacokinetic advantages. The Phase 2 timeline suggests E7090 may not achieve market entry until 2027–2029 at earliest, assuming successful Phase 3 progression.
Future Catalysts: Key milestones include Phase 2 efficacy and safety data readout, potential Phase 3 initiation, regulatory interactions with major health authorities, and biomarker-driven patient stratification strategies. Combination therapy exploration with immunotherapy or other targeted agents may also emerge.
Market Considerations: Cholangiocarcinoma represents a smaller oncology market than many solid tumors, but FGFR-driven disease enrichment could support focused commercial strategies. Pricing and reimbursement will depend on comparative efficacy and safety versus approved and near-approved competitors.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.