AstraZeneca PLC

AstraZeneca PLC works on 42 rare diseases tracked on Trial Friend, including Adrenocortical Carcinoma, ATTR Amyloidosis (Transthyretin Amyloidosis), Atypical Hemolytic Uremic Syndrome and 39 more, with 24 recruiting clinical trials and 22 FDA-approved rare disease drugs.

AstraZeneca entered the rare disease market with its 2021 acquisition of Alexion Pharmaceuticals for $39 billion, significantly expanding its portfolio of rare disease treatments. The company now operates a dedicated rare disease division addressing complement-mediated and other rare genetic disorders.

Type
Diversified Pharma
Ticker
AZN
Headquarters
Cambridge, United Kingdom
Founded
1999
24
Active Rare Disease Trials
22
Approved Rare Disease Drugs
42
Rare Diseases in Portfolio
27
Years Active
FDA decision ahead
The FDA is due to decide on Ultomiris (ravulizumab) for IgA nephropathy in Q4 2026.
The FDA is due to decide on Efzimfotase alfa (ALXN1850) for Hypophosphatasia in First half of 2027.
See all upcoming rare disease FDA decisions →

Focus areas at AstraZeneca PLC

Within its broader pharmaceutical portfolio, AstraZeneca PLC has active clinical trial programs and drug development efforts across 42 rare diseases, including Adrenocortical Carcinoma, ATTR Amyloidosis (Transthyretin Amyloidosis), Atypical Hemolytic Uremic Syndrome, Bullous Pemphigoid, Cholangiocarcinoma, and 37 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by AstraZeneca PLC, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

AstraZeneca PLC is headquartered in Cambridge, United Kingdom, founded in 1999, publicly traded under the ticker symbol AZN. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

AstraZeneca PLC Drug Pipeline

AstraZeneca PLC has 24 active clinical trials across 4 development stages, with 24 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of AstraZeneca PLC's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand AstraZeneca PLC's pipeline
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3
Early Phase / Phase 13 trials
Recruiting
Recruiting
12
Phase 212 trials
Endometrial Cancer+4 more
Recruiting
Adenoid Cystic Carcinoma
Recruiting
B-cell Non-Hodgkin Lymphoma+2 more
Recruiting
6
Phase 36 trials
Obesity or Overweight+2 more
Recruiting
Advanced Hepatocellular Carcinoma
Recruiting
Hormone-Sensitive Prostate Cancer
Recruiting
Biliary Tract Cancer
Recruiting
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Recruiting
3
Other3 trials
Recruiting
Carcinoma, Non-Small-Cell Lung+4 more
Recruiting

AstraZeneca PLC Clinical Trials (24)

Active and recruiting clinical trials sponsored by AstraZeneca PLC, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about AstraZeneca PLC's trials
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RECRUITINGPHASE3Recently updatedNCT07776509

A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

Intervention: Lenbelintide, Placebo

Obesity or OverweightWeight-Related ComorbidityWith/Without Diabetes Mellitus, Type 2

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.

Ages 18 Years+96 locations
View full study
RECRUITINGPHASE2Recently updatedNCT05489211

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Intervention: Datopotamab deruxtecan (Dato-DXd), Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin, Bevacizumab, Rilvegostomig, Prednisone/ prednisolone, Cisplatin

Endometrial CancerGastric CancerMetastatic Castration-resistant Prostate CancerOvarian CancerColorectal Cancer

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Ages 18 Years - 130 Years96 locations
View full study
RECRUITINGRecently updatedNCT06465810

Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis

Intervention: Treatment of transthyretin (ATTR) amyloidosis in observational study setting

Transthyretin AmyloidosisATTR-CMATTRv-PNATTRATTR-Mixed

The MaesTTRo study aims to enroll a global cohort of patients with transthyretin (ATTR) amyloidosis to longitudinally observe the natural course of the disease and describe real-world treatment patterns and outcomes. In addition, information on the effectiveness of ATTR amyloidosis treatments, including eplontersen, which is a ligand-conjugated antisense oligonucleotide gene silencing treatment targeting activity against both the mutant and wild-type TTR protein, will be collected.

Ages 18 Years - 130 Years89 locations
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RECRUITINGPHASE2Recently updatedNCT07162480

Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)

Intervention: P-Sam

Adenoid Cystic Carcinoma

Phase II open label study designed to evaluate the efficacy and safety of P-Sam in patients with aggressive, solid, NOTCH mutant or p63 low (B7-H4 high) R/M ACC-I patients.

Ages 18 Years+1 location
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RECRUITINGPHASE2Recently updatedNCT06858735

HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

Intervention: Durvalumab, Gemcitabine, Cisplatin

This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.

Ages 18 Years+1 location
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT05883644

Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

Intervention: Durvalumab, Tremelimumab

Advanced Hepatocellular Carcinoma

This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

Ages 18 Years - 130 Years40 locations
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RECRUITINGPHASE2Recently updatedNCT07571746

A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease

Intervention: Surovatamig

The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.

Ages 18 Years - 75 Years24 locations
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AstraZeneca PLC FDA-Approved Drugs (22)

Medications developed or marketed by AstraZeneca PLC that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
ALBUTEROL SULFATE AND BUDESONIDE
Corticosteroid [EPC]
AIRSUPRA
respiratory (inhalation)
Jan 10, 2023
TICAGRELOR
P2Y12 Platelet Inhibitor [EPC]
BRILINTA
oral
Jul 20, 2011
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
Corticosteroid [EPC]
Budesonide and Formoterol Fumarate Dihydrate
respiratory (inhalation)
Apr 23, 2026
EXENATIDE
GLP-1 Receptor Agonist [EPC]
Byetta
subcutaneous
Apr 28, 2005
ACALABRUTINIB
Kinase Inhibitor [EPC]
CALQUENCE
oral
—Oct 31, 2017

AstraZeneca PLC Trial Locations

AstraZeneca PLC clinical trials are running at 1,163 sites in 37 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
205▼
China
170▼
Japan
98▼
France
71▼
Spain
60▼
Germany
57▼
United Kingdom
50▼
Canada
44▼
Italy
39▼
Brazil
36▼
South Korea
35▼
Taiwan
34▼

Rare Disease Focus Areas (42)

Diseases targeted by AstraZeneca PLC's clinical trial and drug development programs

Adrenocortical CarcinomaRare Cancers

Adrenocortical carcinoma is a rare, aggressive cancer of the adrenal cortex, the outer layer of the adrenal glands that sit on top of each kidney. These glands produce essential hormones including cor...

Prevalence: About 1-2 per million people per year; approximately 600 new cases per year in the U.S.
ATTR Amyloidosis (Transthyretin Amyloidosis)Metabolic & Lysosomal

ATTR amyloidosis is a rare progressive disease where abnormal transthyretin protein accumulates as amyloid deposits in the heart, nerves, and other organs. It can be inherited (hereditary ATTR) or dev...

Prevalence: Approximately 5,000 to 7,000 new cases diagnosed annually in the U.S.
Atypical Hemolytic Uremic SyndromeKidney & Renal

Atypical Hemolytic Uremic Syndrome (aHUS) is a rare kidney disease caused by uncontrolled activation of the complement system, a part of the immune system that normally helps fight infection. This act...

Prevalence: Approximately 1-2 cases per million people per year; rare form of HUS accounting for 5-10% of all HUS cases
Bullous PemphigoidDermatologic

Bullous pemphigoid is an autoimmune blistering disorder caused by autoantibodies against basement membrane proteins, particularly BP180 and BP230. The condition leads to formation of large fluid-fille...

Prevalence: Approximately 2-23 per million people per year; incidence increases sharply with age
CholangiocarcinomaRare Cancers

Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts, the thin tubes that carry digestive fluid (bile) from the liver to the small intestine. It can occur inside the liver (...

Prevalence: About 8,000 new cases per year in the U.S.; rising incidence worldwide
Chronic Graft-versus-Host DiseaseBlood & Immune

Chronic graft-versus-host disease is an immune-mediated complication after allogeneic stem cell or bone marrow transplant, in which donor immune cells attack the recipient's tissues. It can affect the...

Prevalence: Affects 30 to 70% of patients who receive allogeneic hematopoietic stem cell transplant; approximately 14,000 new cases annually in the U.S.

Patient Resources

Organizations and resources related to AstraZeneca PLC's rare disease focus areas

Frequently Asked Questions About AstraZeneca PLC

Common questions about AstraZeneca PLC's rare disease programs, clinical trials, and treatments.