鶹ý

Latest Major R&D Pipeline

Major R&D Pipeline

(As of May 15, 2024)

  • ●:Development progress from January 2024 onwards ○:Development progress from April 2023 onwards

Neurology

Dementia

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DiseaseStudyRegionDevelopment Stage
「Leqembi」(lecanemab/BAN2401) Treatment for Alzheimer’s disease / anti-Aβ protofibril antibody In-license (BioArctic AB) Injection Joint development with Biogen Inc.
Early Alzheimer’s disease 301 (Clarity AD) US Traditional approval
(July 2023)
Japan Approval (September 2023)
China Approval (January 2024)
Europe Submission
(accepted: January 2023)
Asia (South Korea) Submission
(June 2023)
IV maintenance dosing for early AD (Additional Dosage and Administration) 201/301 US Submission (March 2024)
Maintenance dosing of a subcutaneous injection formulation for early AD (Additional Formulation) 301 US Rolling Submission (initiated: May 2024)
Preclinical Alzheimer’s disease 303 (AHEAD 3-45) Japan/US/Europe
E2814 anti-MTBR tau antibody Collaboration (University College London) Injection
Alzheimer’s disease Tau Nexgen Japan/US/Europe Ⅱ/Ⅲ
103 US/Europe Ⅰ/Ⅱ
E2511 Synapse regenerant In-house Oral
Alzheimer’s disease - US
2025〶ı-dzܲ〶ı𳦳پDz
Alzheimer’s disease - US

Neurological diseases other than dementia

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DiseaseStudyRegionDevelopment Stage
「Fycompa」(perampanel/E2007) Antiepileptic agent / AMPA receptor antagonist In-house Oral / Injection
Injection formulation (Additional Formulation) - Japan Approval (January 2024)
Adjunctive therapy for primary generalized tonic-clonic seizures (Additional Indication) 332 China Approval (April 2024)
「Dayvigo」(lemborexant/E2006) Insomnia treatment / Orexin receptor antagonist In-house Oral
Insomnia disorder 311 China Submission (accepted: January 2024)
mecobalamin/E0302) Treatment for Amyotrophic lateral sclerosis (ALS) In-house Injection
ALS JETALS Japan Submission (January 2024)
lorcaserin/E2023 Treatment for Dravet syndrome / serotonin 2C receptor agonist In-license (Arena Pharmaceuticals) Oral
Dravet syndrome 304 US
2086〶ı-dzܲ〶İ
Narcolepsy - US
4017〶ı-dzܲ〶İ
Chemotherapy-induced peripheral neuropathy (Development conducted by EA Pharma) - Japan

Oncology

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DiseaseStudyRegionDevelopment Stage
「Lenvima/Kisplyx」(lenvatinib/E7080) Anticancer agent / kinase inhibitor In-house Oral
In combination with anti-PD-1 therapy pembrolizumab, joint development with Merck & Co., Inc., Rahway, NJ, USA, through an affiliate (Additional Indication)
Hepatocellular carcinoma (in combination with transcatheter arterial chemoembolization) / First-line LEAP-012 Japan/US/Europe/China
Esophageal carcinoma (in combination with chemotherapy) / First-line LEAP-014 Japan/US/Europe/China
Gastric cancer (in combination with chemotherapy) / First-line LEAP-015 Japan/US/Europe/China
Head and neck cancer / Second-line LEAP-009 US/Europe
In combination with anti-PD-1 antibody nivolumab, joint development with Ono Pharmaceutical (Additional Indication)
Hepatocellular carcinoma - Japan
「Halaven」(eribulin/E7389) Anticancer agent / microtubule dynamics inhibitor In-house Injection
Monotherapy (Additional Formulation)
Liposomal formulation - Japan/Europe
In combination with anti-PD-1 antibody nivolumab, joint development with Ono Pharmaceutical (Additional Formulation)
Liposomal formulation 120 Japan Ⅰ/Ⅱ
tasurgratinib/E7090 Anticancer agent / FGFR1, FGFR2, FGFR3 inhibitor In-house Oral
Biliary tract cancer with FGFR2 gene fusion 201 Japan Submission (December 2023)
Breast cancer - Japan
farletuzumab ecteribulin(FZEC)/MORAb-202 Anticancer agent / Folate receptor α targeted antibody drug conjugate In-house Injection Joint development with Bristol Myers Squibb
Non-small cell lung cancer 203 US/Europe
Ovarian cancer, peritoneal cancer, fallopian tube cancer 205 Japan/US/Europe
Solid tumors 201 US/Europe Ⅰ/Ⅱ
BB-1701 Anticancer agent / HER2 targeted antibody drug conjugate In-house Injection
Breast cancer 205 JP/US
E7386 Anticancer agent / CBP/β-catenin interaction inhibitor Collaboration (PRISM BioLab) Oral
Solid tumors (in combination with pembrolizumab) 201 Japan/US/Europe Ⅰ/Ⅱ
Solid tumors - Japan/US/Europe
Solid tumors (in combination with lenvatinib) - Japan/US/Europe
H3B-6545 Anticancer agent / ERα inhibitor In-house Oral
Breast cancer (in combination with CDK4/6 inhibitor palbociclib) - US/Europe
E7130 Collaboration (Harvard University) Injection
Solid tumors - Japan
7766〶ı-dzܲ〶ı𳦳پDz
Solid tumors - US/Europe

Global Health

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DiseaseSponsor of studyRegionDevelopment Stage
fosravuconazole/E1224 Antifungal agent / ergosterol synthesis inhibitor In-house Oral
Eumycetoma
*Supported by GHIT fund
*鶹ý is mainly responsible for non-clinical studies and the provision of the investigational drug.
DNDi・Mycetoma Research Center of the University of Khartoum Sudan Ⅱb/Ⅲ
SJ733 Antimalarial agent / ATP4 inhibitor Co-development (University of Kentucky) Oral
Malaria
*Supported by GHIT fund
*鶹ý is responsible for the provision of drug substance and formulation manufacturing
University of Kentucky Peru
AWZ1066S Antifilarial agent / antiwolbachia mechanism Co-development (Liverpool School of Tropical Medicine) Oral
Lymphatic filariasis
*Supported by the GHIT Fund and Medical Research Council in the UK
*鶹ý is responsible for the provision of drug substance and formulation manufacturing
Liverpool School of Tropical Medicine UK

Gastrointestinal Disorders

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DiseaseStudyRegionDevelopment stage
MOVICOL/(AJG555) Chronic constipation treatment / polyethylene glycol preparation In-license (Norgine) Oral
Chronic constipation in children under 2 years of age (Additional Dosage and Administration) (Development conducted by EA Pharma) CT3 Japan
347〶ı-dzܲ〶İ
Inflammatory bowel disease (Development conducted by EA Pharma) - Europe
1080〶ı-dzܲ〶İ
Inflammatory bowel disease (Development conducted by EA Pharma) - Europe
3571〶ı-dzܲ〶İ
Metabolic dysfunction-associated steatohepatitis (Development conducted by EA Pharma) - Japan

Other

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DiseaseStudyRegionDevelopment stage
dotinurad / FYU-981 Treatment for Hyperuricemia and Gout / selective URAT1 inhibitor In-license (FUJI YAKUHIN) Oral
Gout, hyperuricemia - Asia (Philippines) Submission (September 2023)
Gout 301 China

Submission (accepted: January 2024)

E6742 Treatment for Systemic lupus erythematosus / TLR 7/8 inhibitor In-house Oral
Systemic lupus erythematosus 101 Japan Ⅰ/Ⅱ
E8001 In house Injection
Rejection reaction associated with organ transplantation - Japan