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Astellas Pharma

ALPMY
$24.13B
Large Cap
NASDAQHealthcare🇺🇸North America13.6K employees

Drugs in Pipeline

206

Phase 3 Programs

114

Upcoming Catalysts

5

Next Catalyst

Dec 2026

Market Overview

Stock performance and key metrics

ALPMY News
Catalyst Timeline

5 upcoming, 0 past

Drug Pipeline

OPT-80

Phase 3

Clostridium Difficile

Setidegrasib

Phase 3

Pancreatic Cancer

daclizumab

Phase 3

Kidney Transplantation

nitrazepam

Phase 3

Sleep Initiation and Maintenance Disorders

FK506E (modified release tacrolimus)

Phase 3

Liver Transplantation

Famotidine

Phase 3

Gastroesophageal Reflux

avacincaptad pegol

Phase 3

Geographic Atrophy

febuxostat

Phase 3

Gout

Capsaicin 8%

Phase 3

Diabetic Peripheral Neuropathy

Mirabegron

Phase 3

Neurogenic Detrusor Overactivity

Micafungin

Phase 3

Candidiasis, Oral

ipragliflozin

Phase 3

Diabetes Mellitus

RSD1235

Phase 3

Atrial Fibrillation

ASP0113

Phase 3

Allogeneic Hematopoietic Cell Transplant

pudexacianinium chloride

Phase 3

Intraoperative Ureter Visualization

roxadustat

Phase 3

Hemodialysis Chronic Kidney Disease Patients With Anemia

tolterodine

Phase 3

Urinary Bladder, Overactive

Solifenacin succinate

Phase 3

Urinary Bladder, Overactive

YM178

Phase 3

Urinary Bladder, Overactive

nateglinide

Phase 3

Type 2 Diabetes Mellitus

Darbepoetin alfa

Phase 3

Anemia in Chronic Kidney Disease in Non-dialysis Patients

Fezolinetant

Phase 3

Hot Flashes

ASP8825

Phase 3

Restless Legs Syndrome

DPP-4 inhibitor

Phase 3

Type 2 Diabetes Mellitus

YM060

Phase 3

Irritable Bowel Syndrome

Enzalutamide

Phase 3

Progressive Metastatic Prostate Cancer

Cyclosporine

Phase 3

Heart Diseases

ASP1585

Phase 3

Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Certolizumab pegol

Phase 3

Rheumatoid Arthritis

ASP1941

Phase 3

Type 2 Diabetes Mellitus

Tacrolimus Cream

Phase 3

Psoriasis

YM150

Phase 3

Arthroplasty, Replacement, Knee

tacrolimus ointment

Phase 3

Dermatitis, Atopic

FK949E

Phase 3

Bipolar Disorder

CDP870

Phase 3

Active Rheumatoid Arthritis

linaclotide

Phase 3

Irritable Bowel Syndrome With Constipation (IBS-C)

Prograf

Phase 3

Liver Transplantation

isavuconazole

Phase 3

Aspergillosis

FK506

Phase 3

Keratoconjunctivitis

tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)

Phase 3

Lower Urinary Tract Symptoms

MMF

Phase 3

Kidney Transplantation

OSI-906

Phase 3

Adrenocortical Carcinoma

Gilteritinib

Phase 3

Advanced Solid Tumors

peficitinib

Phase 3

Psoriasis

FK199B

Phase 3

Sleep Initiation and Maintenance Disorders

tamsulosin hydrochloride OCAS 0.4 mg

Phase 3

Benign Prostatic Hyperplasia

caspofungin

Phase 3

Candidiasis, Oral

degarelix

Phase 3

Prostatic Neoplasms

YM443

Phase 3

Indigestion

Solifenacin succinate suspension

Phase 3

Urinary Bladder, Overactive

Tacrolimus capsule

Phase 3

Myasthenia Gravis

Tacrolimus ointment 0.1%

Phase 3

Dermatitis, Atopic

mirabegron 25 mg

Phase 3

Urinary Bladder Diseases

basiliximab

Phase 3

Kidney Transplantation

tolterodine ER

Phase 3

Urinary Bladder, Overactive

Corticosteroids

Phase 3

Liver Transplantation

Midostaurin

Phase 3

Acute Myeloid Leukemia

regadenoson

Phase 3

Coronary Artery Disease (CAD)

Ipragliflozin L-proline

Phase 3

Type 2 Diabetes Mellitus

Sevelamer hydrochloride

Phase 3

Hyperphosphatemia

cyclosporine microemulsion

Phase 3

Kidney Transplantation

MR4

Phase 3

Kidney Transplantation

Tamuslosin

Phase 3

Urinary Tract Diseases

LoDAC (Low Dose Cytarabine)

Phase 3

Leukemia, Acute Myeloid (AML)

Interferon alfacon-1

Phase 3

Hepatitis C

Sulfonylurea

Phase 3

Type 2 Diabetes Mellitus

DA

Phase 3

Chronic Kidney Disease

methylprednisolone and prednisone

Phase 3

Kidney Transplantation

Tacrolimus capsules

Phase 3

Lupus Nephritis

overencapsulated caffeine

Phase 3

Coronary Artery Disease (CAD)

Tamusulosin

Phase 3

Urinary Tract Diseases

Etanercept

Phase 3

Rheumatoid Arthritis

QUTENZA

Phase 3

Painful Diabetic Peripheral Neuropathy (PDPN)

Plaebo

Phase 3

Rheumatoid Arthritis (RA)

FK506MR capsule

Phase 3

Liver Transplantation

Voriconazole

Phase 3

Aspergillosis

Tacrolimus, modified release

Phase 3

Kidney Transplantation

FK506E

Phase 3

Heart Transplantation

Alefacept

Phase 3

Psoriatic Arthritis

Epoetin alfa

Phase 3

Anemia

Ra223

Phase 3

Prostate Cancer

Exisulind

Phase 3

NSCLC

Enfortumab vedotin

Phase 3

Metastatic Urothelial Cancer

Fidaxomicin oral suspension

Phase 3

Clostridium Difficile-associated Diarrhea (CDAD)

ASP2138

Phase 3

Gastric Adenocarcinoma

Prednisolone

Phase 3

Metastatic Castration Resistant Prostate Cancer

fluconazole

Phase 3

Invasive Candidiasis

TRK-100STP high dose

Phase 3

Chronic Renal Failure

Rabbit Anti-Human Thymocyte Globulin

Phase 3

Pancreas-Kidney Transplantation

Goserelin

Phase 3

Prostate Cancer

G-CSF

Phase 3

AML With FLT3 Mutation

ONO-5920

Phase 3

Involutional Osteoporosis

Regadenoson; Optison

Phase 3

Coronary Artery Disease

Folinic acid (leucovorin or local equivalent)

Phase 3

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer

Minodronic acid hydrate

Phase 3

Involutional Osteoporosis

YM177

Phase 3

Post Operative Pain

micafungin (Mycamine)

Phase 3

Fungemia

VESIcare®

Phase 3

Urinary Bladder, Overactive

CZP

Phase 3

Rheumatoid Arthritis

Liposomal Amphotericin B

Phase 3

Candidiasis

YM529 / ONO-5920

Phase 3

Osteoporosis

Ramosetron

Phase 3

Vomiting

Advagraf

Phase 3

Heart Transplantation

FK506MR

Phase 3

Kidney Transplantation

Simulect

Phase 3

Kidney Transplantation

Prograf-XL

Phase 3

Liver Transplantation

Zolpidem MR

Phase 3

Sleep Initiation and Maintenance Disorders

alpha glucosidase inhibitor

Phase 3

Type 2 Diabetes Mellitus

leuprorelin acetate

Phase 3

Prostate Cancer

Tacrolimus modified-release

Phase 3

Liver Transplantation

zolbetuximab

Phase 3

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer

Steroids

Phase 3

De Novo Kidney Transplantation

Androgen deprivation therapy (ADT)

Phase 3

Metastatic Hormone Sensitive Prostate Cancer

Tacrolimus (Prograf®)

Phase 3

Rheumatoid Arthritis

ASP1650

Phase 2

Incurable Platinum Refractory Germ Cell Tumors

ASP0456

Phase 2

Chronic Constipation

Midazolam

Phase 2

Acute Myeloid Leukemia

Erlotinib

Phase 2

NSCLC

tamsulosin hydrochloride

Phase 2

Lower Urinary Tract Symptoms

YM872 (zonampanel), t-PA (alteplase)

Phase 2

Acute Ischemic Stroke

Bicalutamide

Phase 2

Prostate Cancer

ASP4070

Phase 2

Rhinitis, Allergic, Seasonal

ASP4901

Phase 2

Benign Prostate Hyperplasia

Tacrolimus Inhalation Aerosol

Phase 2

Asthma

ASP2998

Phase 2

Locally Advanced or Metastatic Malignant Solid Tumors

tacrolimus modified release (MR)

Phase 2

Liver Transplantation

Rapamycin

Phase 2

Type 1 Diabetes

Tacrolimus Ointment 0.03%

Phase 2

Dermatitis, Atopic

ASP5541

Phase 2

Prostate Cancer

Mycophenolate Mofetil (MMF)

Phase 2

Kidney Transplantation

Solifenacin

Phase 2

Overactive Bladder

ASP8062

Phase 2

Fibromyalgia

Leuprolide

Phase 2

Prostate Cancer

ASP0819

Phase 2

Fibromyalgia

ASP9831

Phase 2

Non-Alcoholic Steatohepatitis

Isavuconazonium sulfate

Phase 2

Invasive Mucormycosis

FK788

Phase 2

Hepatitis C

OSI-461

Phase 2

Chronic Lymphocytic Leukemia

AGS-1C4D4

Phase 2

Carcinoma, Pancreatic Ductal

ASP2151

Phase 2

Herpes Genitalis

ASP1517

Phase 2

Anemia in Chronic Kidney Disease Patients Not on Dialysis

ASP8477

Phase 2

Post-Herpetic Neuralgia (PHN)

TPC

Phase 2

Metastatic Breast Cancer

ASP7991

Phase 2

Secondary Hyperparathyroidism

ASP1707

Phase 2

Endometriosis

ASP7517

Phase 2

Acute Myeloid Leukemia (AML)

ASP5094

Phase 2

Rheumatoid Arthritis (RA)

Enzalutamide 40 MG

Phase 2

Ovarian Cancer

ASP4345

Phase 2

Schizophrenia

FK614

Phase 2

Diabetes Mellitus

ASKP1240

Phase 2

Psoriasis

XNW27011

Phase 2

Pancreatic Adenocarcinoma Metastatic

steroids, monoclonal anti-IL2R antibody

Phase 2

Hepatitis C

GnRH analog

Phase 2

Prostate Cancer

YM872 (zonampanel)

Phase 2

Cerebrovascular Accident

YM543

Phase 2

Diabetes Mellitus Type 2

MDV3100

Phase 2

Prostate Cancer

Androgen Deprivation

Phase 2

Prostate Cancer

enfortumab vedotin (EV)

Phase 2

Carcinoma, Transitional Cell

ASP8232

Phase 2

Diabetes Mellitus

Idarubicin

Phase 2

Acute Myeloid Leukemia

OSI-211 (Liposomal Lurtotecan)

Phase 2

SCLC

Abiraterone

Phase 2

Metastatic Prostate Cancer

MA09-hRPE

Phase 2

Stargardt's Macular Dystrophy

ASK8007

Phase 2

Rheumatoid Arthritis

ASP1570

Phase 2

Advanced Solid Tumors

ELIGARD

Phase 2

Prostate Cancer

trametinib

Phase 2

Prostate Cancer

FK463

Phase 2

Candidiasis

hydrocortisone acetate ointment 1%

Phase 2

Atopic Dermatitis

Clobetasol cream

Phase 2

Vulvar Lichen Sclerosus

Flutamide

Phase 2

Castration-resistant Prostate Cancer

ASP6294

Phase 2

Bladder Pain Syndrome

FK778

Phase 2

Kidney Transplantation

ASP546C

Phase 2

Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

ASP7962

Phase 2

Osteoarthritis of the Knee

ASP2246

Phase 2

Chronic Ischemic Stroke

Beraprost

Phase 2

Renal Insufficiency, Chronic

MK-3475

Phase 2

Bladder Cancer

ASP8302

Phase 2

Underactive Bladder

epirubicin

Phase 2

CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction

AGS-16C3F

Phase 2

Metastatic Renal Cell Carcinoma

Enzalutamide capsule

Phase 2

Prostate Cancer

quetiapine extended release (XR)

Phase 2

Major Depressive Disorder

Erlotinib Hydrochloride

Phase 2

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

ASP3082

Phase 2

Metastatic/Locally Advanced Non-Small-Cell Lung Cancer

Valacyclovir hydrochloride

Phase 2

Herpes Zoster

ASP3550

Phase 2

Prostatic Neoplasms

warfarin

Phase 2

Atrial Fibrillation

ADT+Docetaxel+Enzalutamide

Phase 2

Prostate Cancer

VCL-CB01

Phase 2

Acute Lymphoblastic Leukemia

ASP3652

Phase 2

Chronic Abacterial Prostatitis

ASP1128

Phase 2

Acute Kidney Injury (AKI)

linsitinib

Phase 2

Advanced Solid Tumors

Trimethoprim and sulfamethoxazole

Phase 2

Kidney Diseases

YM 155

Phase 2

Prostate Cancer

Reldesemtiv

Phase 2

Chronic Obstructive Pulmonary Disease (COPD)

gadofoveset trisodium

Phase 2

Myocardial Ischemia

scAAV9.U7.ACCA

Phase 2

Duchenne Muscular Dystrophy

CP-461

Phase 2

Crohn's Disease

Methylprednisolone

Phase 2

X-Linked Myotubular Myopathy

Tacrolimus prolonged release

Phase 2

Intestine Transplantation

Bleselumab

Phase 2

Kidney Transplantation

YM155

Phase 2

Lung Cancer

Lexiscan

Phase 2

Cardiovascular Diseases

Anti-IL2R AB

Phase 2

Liver Transplantation

Market-Implied Move
Regulatory Approvals

Frequently asked questions

What is in Astellas Pharma's drug pipeline?

CatalystAlert tracks 206 drug candidates in Astellas Pharma's (ALPMY) pipeline across Phase 3, Phase 2. Its lead program is OPT-80 (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.

When is Astellas Pharma's next FDA catalyst?

Astellas Pharma's (ALPMY) next tracked catalyst is a Phase 2 expected December 16, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.

How do I track ALPMY biotech catalysts?

Add ALPMY to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Astellas Pharma's live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.

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Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply