Major R&D Pipeline
(As of August 2, 2024)
-
¡ñ£ºDevelopment progress from April 2024 onwards
Neurology
Dementia
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¡¡
| Disease | Study | Region | Development Stage | |
|---|---|---|---|---|
| ¡¸Leqembi¡¹(lecanemab/BAN2401)¡¡Treatment for Alzheimer’s disease (AD) / anti-Aβ protofibril antibody¡¡In-license (BioArctic AB)¡¡Injection (intravenous infusion, subcutaneous injection)¡¡Joint development with Biogen Inc. | ||||
| Early AD | 301 (Clarity AD) | Asia (South Korea) | ¡ñ | Approval (April 2024) |
| Europe | Submission
(accepted: January 2023) |
|||
| IV maintenance dosing for early AD (Additional Dosage and Administration) | 201£¯301 | US | ¡ñ | Submission (June 2024) |
| Maintenance dosing of a subcutaneous injection formulation for early AD (Additional Formulation) | 301 | US | ¡ñ | Rolling Submission (initiated: May 2024) |
| Preclinical AD | 303 (AHEAD 3-45) | Japan/US/Europe | ±Ê¢ó | |
| E2814¡¡anti-MTBR tau antibody¡¡Collaboration (University College London)¡¡Injection | ||||
| Dominantly inherited AD | Tau Nexgen | JP/US/EU | ±Ê¢ò/¢ó | |
| 103 | US/EU | ±Ê¢ñ²ú/¢ò | ||
| E2511¡¡TrkA integrated synapse regenerant ±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| AD | - | US | ±Ê¢ñ | |
| E2025¡¡Anti-EphA4 antibody¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡±õ²ÔÂá±ð³¦³Ù¾±´Ç²Ô | ||||
| AD | - | US | ±Ê¢ñ | |
Neurological diseases other than dementia
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| Disease | Study | Region | Development Stage | |
|---|---|---|---|---|
| ¡¸Fycompa¡¹(perampanel/E2007)¡¡Antiepileptic agent / AMPA receptor antagonist¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô / Injection | ||||
| Adjunctive therapy for primary generalized tonic-clonic seizures (Additional Indication) | 332 | China | ¡ñ | Approval (April 2024) |
| ¡¸Dayvigo¡¹(lemborexant/E2006)¡¡Insomnia treatment / Orexin receptor antagonist¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Insomnia disorder | 311 | China | Submission (accepted: January 2024) | |
| mecobalamin/E0302)¡¡Treatment for Amyotrophic lateral sclerosis (ALS)¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡±õ²ÔÂá±ð³¦³Ù¾±´Ç²Ô | ||||
| ALS | JETALS (IIS) | Japan | Submission (January 2024) | |
| lorcaserin/E2023¡¡Treatment for Dravet syndrome / serotonin 2C receptor agonist¡¡In-license (Arena Pharmaceuticals)¡¡Oral | ||||
| Dravet syndrome | 304 | US | ±Ê¢ó | |
| E2086¡¡Orexin receptor agonist¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Narcolepsy | - | US | ±Ê¢ñb | |
| EA4017¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Chemotherapy-induced peripheral neuropathy (Development conducted by EA Pharma) | - | Japan | ±Ê¢ñ | |
Oncology
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| Disease | Study | Region | Development Stage | |
|---|---|---|---|---|
| ¡¸Lenvima/Kisplyx¡¹(lenvatinib/E7080)¡¡Anticancer agent / kinase inhibitor¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| 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 | JP/US/EU/CH | ±Ê¢ó | |
| Esophageal carcinoma (in combination with chemotherapy) / First-line | LEAP-014 | JP/US/EU/CH | ±Ê¢ó | |
| Gastric cancer (in combination with chemotherapy) / First-line | LEAP-015 | JP/US/EU/CH | ±Ê¢ó | |
| Head and neck cancer / Second-line | LEAP-009 | US/EU | ±Ê¢ò | |
| In combination with anti-PD-1 antibody nivolumab, joint development with Ono Pharmaceutical (Additional Indication) | ||||
| Hepatocellular carcinoma | - | Japan | ±Ê¢ñb | |
| ¡¸Halaven¡¹(eribulin/E7389)¡¡Anticancer agent / microtubule dynamics inhibitor¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡±õ²ÔÂá±ð³¦³Ù¾±´Ç²Ô | ||||
| Monotherapy (Additional Formulation) | ||||
| Liposomal formulation | - | JP/EU | ±Ê¢ñ | |
| In combination with anti-PD-1 antibody nivolumab, joint development with Ono Pharmaceutical (Additional Formulation) | ||||
| Liposomal formulation | 120 | Japan | ±Ê¢ñ²ú/¢ò | |
| tasurgratinib/E7090¡¡Anticancer agent / FGFR1, FGFR2, FGFR3 inhibitor¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Biliary tract cancer with FGFR2 gene fusion | 201 | Japan | Submission (December 2023) | |
| Breast cancer | - | Japan | ±Ê¢ñb | |
| farletuzumab ecteribulin£¨FZEC£©/MORAb-202¡¡Anticancer agent / Folate receptor α targeted antibody drug conjugate¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡±õ²ÔÂá±ð³¦³Ù¾±´Ç²Ô | ||||
| Non-small cell lung cancer | 203 | US/EU | ±Ê¢ò | |
| Ovarian cancer, peritoneal cancer, fallopian tube cancer | 205 | JP/US/EU | ±Ê¢ò | |
| Solid tumors | 201 | US/EU | ±Ê¢ñ/¢ò | |
| BB-1701¡¡Anticancer agent / HER2 targeted antibody drug conjugate¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡±õ²ÔÂá±ð³¦³Ù¾±´Ç²Ô | ||||
| Breast cancer | 205 | JP/US | ±Ê¢ò | |
| E7386¡¡Anticancer agent / CBP/β-catenin interaction inhibitor¡¡Collaboration (PRISM BioLab)¡¡Oral | ||||
| Solid tumors (in combination with pembrolizumab) | 201 | JP/US/EU | ±Ê¢ñ²ú/¢ò | |
| Solid tumors | - | JP/US/EU | ±Ê¢ñ | |
| Solid tumors (in combination with lenvatinib) | - | JP/US/EU | ±Ê¢ñb | |
| H3B-6545¡¡Anticancer agent / ERα inhibitor¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Breast cancer (in combination with CDK4/6 inhibitor palbociclib) | - | US/EU | ±Ê¢ñb | |
| E7130¡¡ Anticancer agent¡¡Collaboration (Harvard University)¡¡Injection | ||||
| Solid tumors | - | Japan | ±Ê¢ñ | |
| E7766¡¡Anticancer agent¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡±õ²ÔÂá±ð³¦³Ù¾±´Ç²Ô | ||||
| Solid tumors | - | US/EU | ±Ê¢ñb | |
Global Health
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| Disease | Sponsor of study | Region | Development Stage | |
|---|---|---|---|---|
| fosravuconazole/E1224¡¡Antifungal agent / ergosterol synthesis inhibitor¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Eumycetoma
*Supported by GHIT fund *ÎÚÑ»´«Ã½ is mainly responsible for non-clinical studies and the provision of the investigational drug. |
DNDi?Mycetoma Research Center of the University of Khartoum | Sudan | ±Ê¢òb/¢ó | |
| SJ733¡¡Antimalarial agent / ATP4 inhibitor¡¡Co-development (University of Kentucky)¡¡Oral | ||||
| Malaria
*Supported by GHIT fund *ÎÚÑ»´«Ã½ is responsible for the provision of drug substance and formulation manufacturing |
University of Kentucky | Peru | ±Ê¢ò | |
| 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 *ÎÚÑ»´«Ã½ is responsible for the provision of drug substance and formulation manufacturing |
Liverpool School of Tropical Medicine | UK | ±Ê¢ñ | |
Gastrointestinal Disorders
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| Disease | Study | Region | Development 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 | ±Ê¢ó | |
| AJM347¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Inflammatory bowel disease (Joint development conducted by EA Pharma with Ensho Therapeutics, Inc) | - | EU | ±Ê¢ñ | |
| EA1080¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Inflammatory bowel disease (Joint development conducted by EA Pharma with Ensho Therapeutics, Inc) | - | EU | ±Ê¢ñ | |
| EA3571¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Metabolic dysfunction-associated steatohepatitis (Development conducted by EA Pharma) | - | Japan | ±Ê¢ñ | |
Other
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| Disease | Study | Region | Development 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¡¡±õ²Ô-³ó´Ç³Ü²õ±ð¡¡°¿°ù²¹±ô | ||||
| Systemic lupus erythematosus | 101 | Japan | ±Ê¢ñ/¢ò | |
| E8001¡¡In house¡¡Injection | ||||
| Rejection reaction associated with organ transplantation | - | Japan | ±Ê¢ñ | |