Astellas
Also known as: APGDI | APGD, Medical Affairs, Americas | Astellas, | ASTELLAS | Astellas Gene Therapies | Astellas Global Development | Astellas Institute for Regenerative Medicine | Astellas Medical Affairs, Americas | Astellas Phama Global Development | Astellas Pharma BV | Astellas Pharma Canada, Inc. | Astellas Pharma China, Inc. | Astellas Pharma Clinical Pharmacology & Exploratory Dev. | Astellas Pharma Co. Ltd (APCL) | Astellas Pharma Europe B.V. | Astellas Pharma Europe BV (APEB) | Astellas Pharma Europe Limited | Astellas Pharma Europe Ltd. | Astellas Pharma Global Development | Astellas Pharma Global Development - EU | Astellas Pharma Global Development, Inc. | Astellas Pharma Global Development, Inc. (APGD) | Astellas Pharma Global Development, Inc., Medical Affairs, Americas | Astellas Pharma GmbH | Astellas Pharma Inc | Astellas Pharma Inc., Japan | Astellas Pharma Indonesia | Astellas Pharma Indonesia Inc. | Astellas Pharma Korea, Inc. | Astellas Pharma Russian affiliate | Astellas Pharma S.A.S. | Astellas Pharma Singapore Pte. Ltd. | Astellas Pharma s.r.o. | Astellas Pharma Taiwan, Inc. | Astellas Pharma US, Inc. | Astellas Pharm. Inc. | Astellas Scientific & Medical Affairs, Inc. | Clinical Development Administration Dept., Astellas Pharma Inc. | Clinical Development, Astellas Pharma Inc. | Clinical Development III, Astellas Pharm. Inc. | Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive | Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ | Si Pharmaceuticals | SI PHARMS | ZAO Astellas Pharma Russia
Highest phase reached
Phase 4
First clinical trial
Jan 1, 2005First marketed drug
Jan 1, 2005First NDA
Dec 29, 2005Last known activity
Dec 20, 2025
Timeline
1990s
- Apr 8, 1994
tacrolimus— NDA Secondary Org
2000s
- Jan 1, 2005
Astellas— Founded
- Jan 1, 2005
Fujisawa— Acquired
- Jan 1, 2005
Yamanouchi Pharmaceuticals— Acquired
- Mar 1, 2006
Dynogen Pharmaceuticals— Acquired
- Dec 10, 2007
Agensys, Inc.— Acquired
2010s
- Jun 9, 2010
OSI Pharmaceuticals— Acquired
- May 1, 2011
Perseid Therapeutics LLC— Acquired
- Mar 6, 2015
isavuconazonium— NDA Organization
- Nov 17, 2015
Leo Pharma— Acquired By - Feb 10, 2016
Ocata Therapeutics— Acquired
- Oct 28, 2016
Ganymed Pharmaceuticals AG— Acquired
- Apr 3, 2017
Ogeda S.A.— Acquired
- Dec 1, 2017
Mitobridge— Acquired
- Feb 13, 2018
Universal Cells Inc.— Acquired
- Aug 10, 2018
Quethera— Acquired
- Dec 14, 2018
Potenza Therapeutics— Acquired
- Dec 3, 2019
Audentes Therapeutics— Acquired
2020s
- May 1, 2023
Iveric Bio— Acquired
- Aug 4, 2023
avacincaptad pegol— Marketing Organization
- Dec 21, 2023
Propella Therapeutics— Acquired
Drugs by trial phase (402 distinct, 1166 trials)
Phase 4 (69 own, 11 via acquisition)
Phase 3 (68 own, 27 via acquisition)
Phase 2 (87 own, 26 via acquisition)
Phase 1 (87 own, 15 via acquisition)
Other trials (12 own, 0 via acquisition)
Indications
Approved for
Studied for
- Acute Coronary Syndrome
- Acute Disease
- Acute Kidney Injury
- Adenocarcinoma
- Adrenocortical Carcinoma
- Albuminuria
- Alzheimer Disease
- Amyotrophic Lateral Sclerosis
- Anemia
- Anemia, Aplastic
- Anemia, Refractory, with Excess of Blasts
- Anemia, Sickle Cell
- Arteriosclerosis
- Arthritis
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Aspergillosis
- Asthma
- Atherosclerosis
- Atrial Fibrillation
- Atrial Flutter
- Atrophy
- Back Pain
- Bipolar Disorder
- Bone Diseases
- Breast Neoplasms
- Candidemia
- Candidiasis
- Candidiasis, Invasive
- Candidiasis, Oral
- Carcinoma
- Carcinoma, Endometrioid
- Carcinoma, Hepatocellular
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Ovarian Epithelial
- Carcinoma, Pancreatic Ductal
- Carcinoma, Renal Cell
- Carcinoma, Small Cell
- Carcinoma, Squamous Cell
- Carcinoma, Transitional Cell
- Cardiomyopathies
- Cardiovascular Diseases
- Chronic Disease
- Clostridium Infections
- Cognitive Dysfunction
- Colitis
- Colitis, Ulcerative
- Communicable Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Constipation
- Coronary Artery Disease
- Coronary Disease
- Coronavirus Infections
- Crohn Disease
- Cystitis
- Cystitis, Interstitial
- Cytomegalovirus Infections
- Delayed Graft Function
- Depression
- Depressive Disorder
- Dermatitis
- Dermatitis, Allergic Contact
- Dermatitis, Atopic
- Dermatitis, Contact
- Dermatitis, Exfoliative
- Dermatomyositis
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
- Diabetic Neuropathies
- Diarrhea
- Disease
- Dyspepsia
- Eczema
- Edema
- Emergencies
- Encephalitis
- Endometrial Neoplasms
- Endometriosis
- Enuresis
- Ependymoma
- Erectile Dysfunction
- Esophageal Achalasia
- Esophagitis, Peptic
- Fatty Liver
- Fibromyalgia
- Flank Pain
- Fungemia
- Gastroesophageal Reflux
- Glomerulonephritis, IGA
- Glomerulosclerosis, Focal Segmental
- Gout
- Graft vs Host Disease
- Head and Neck Neoplasms
- Heart Diseases
- Heart Failure
- Heart Failure, Diastolic
- Hepatic Insufficiency
- Hepatitis
Marketed drugs (20)
Subsidiaries (16 direct, 19 total across the full acquisition tree)
- Agensys, Inc.
- Audentes Therapeutics
- Dynogen Pharmaceuticals
- Fujisawa
- Ganymed Pharmaceuticals AG
- Iveric Bio
- Mitobridge
- Ocata Therapeutics
- Ogeda S.A.
- OSI Pharmaceuticals
- Perseid Therapeutics LLC
- Potenza Therapeutics
- Propella Therapeutics
- Quethera
- Universal Cells Inc.
- Yamanouchi Pharmaceuticals
- Cell Pathways, Inc. L2
- Lyphomed, Inc. L2
- Mytogen, Inc. L2
Recent trials (50)
- NCT06048081Lead sponsorN/A—
- NCT06048081Study directorN/A—
- NCT04136808Lead sponsorN/A—
- NCT04136808Study directorN/A—
- NCT03409081Study directorN/A—
- NCT03409081Lead sponsorN/A—
- NCT03315299CollaboratorN/A—
- NCT06957691CollaboratorPhase 2Dec 20, 2025
- NCT07287995Lead sponsorPhase 1/Phase 2Dec 15, 2025
- NCT07287995OfficialPhase 1/Phase 2Dec 15, 2025
- NCT06917313CollaboratorPhase 2Nov 30, 2025
- NCT07139977CollaboratorPhase 2Nov 1, 2025
- NCT07110038CollaboratorPhase 2Oct 31, 2025
- NCT07024615Lead sponsorPhase 1Oct 16, 2025
- NCT07024615OfficialPhase 1Oct 16, 2025
Details
- Founded
- Tokyo, JP Jan 1, 2005
- First NDA
- Dec 29, 2005
- Last known activity
- Dec 20, 2025
Designations held
- Orphan drug
- Fast track
- Priority review
- Breakthrough therapy
- Accelerated approval