AstraZeneca plc
Swedish–British multinational pharmaceutical and biotechnology company headquartered in Cambridge, England; develops medications across oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation areas; formed in 1999 through the merger of Swedish Astra AB and British Zeneca Group.
Clinical Trials
3926
414 active
Approvals
42
Total approvals
Agencies
1
Regulatory bodies
Founded
1999
Unknown
9
0.2%
Completed
2747
70.0%
Enrolling By Invitation
1
0.0%
Not yet recruiting
37
0.9%
No Longer Available
4
0.1%
Terminated
224
5.7%
Recruiting
251
6.4%
Suspended
8
0.2%
Approved For Marketing
6
0.1%
Withdrawn
59
1.5%
Active, not recruiting
376
9.6%
- Updated ADAURA results show adjuvant Tagrisso reduced death risk by 47% versus placebo in Stage II to IIIA EGFR-mutated non-small cell lung cancer. - Estimated eight-year survival was 74% with Tagrisso versus 58% with placebo in the primary population, with a hazard ratio of 0.53. - In the broader Stage IB to IIIA population, Tagrisso cut death risk by 48%, with 79% versus 64% estimated eight-year survival.
- The EMA's CHMP has recommended approval of Alexion's Klygefa (gefurulimab) as an add-on therapy for anti-AChR antibody-positive adults with generalised myasthenia gravis. - The positive opinion rests on the pivotal PREVAIL Phase III trial, where gefurulimab improved MG-ADL total score at week 26 versus placebo by -1.6 (95% CI: -2.4, -0.8; p<0.0001). - If approved, Klygefa would be the first and only dual-binding nanobody C5 inhibitor for this population, given once weekly by subcutaneous self-administration via autoinjector. - Klygefa is already approved in Japan and other countries, while submissions based on PREVAIL remain under review in the US, China and additional markets.
- The EMA's CHMP has recommended EU approval of Enhertu as monotherapy for adults with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant therapy. - The opinion rests on DESTINY-Breast05, in which Enhertu cut the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001). - At three years, 92.4% of patients on Enhertu were alive and free of invasive disease versus 83.7% on T-DM1, with no new safety concerns reported. - Enhertu is already approved for this adjuvant indication in the US, Brazil, Canada and India; the European Commission will now review the CHMP recommendation.
- The FDA accepted and granted Priority Review to Alexion's Biologics License Application for efzimfotase alfa in hypophosphatasia patients aged two years and older. - The PDUFA action date is anticipated in the first half of 2027, with regulatory submissions also under review in Japan and other markets. - The filing rests on the three-trial Phase III programme HICKORY, MULBERRY and CHESTNUT, which enrolled 196 patients across 22 countries. - MULBERRY met its primary radiographic endpoint with a median RGI-C difference of 1.67 versus placebo, while HICKORY missed statistical significance on the six-minute walk test.
- The FDA granted accelerated approval to AstraZeneca's camizestrant, sold as Etcamah, for ESR1-mutant metastatic breast cancer on September 5, 2026. - Approval covers use with a CDK4/6 inhibitor in HR-positive, HER2-negative advanced disease, based on a 56% reduction in progression or death risk. - The Phase III SERENA-6 trial reported median progression-free survival of 16 months versus 9.2 months with standard treatment. - The Oncologic Drugs Advisory Committee had voted 6-3 against the risk-benefit profile in April, and confirmatory studies are still required.
- NICE has recommended Enhertu for routine NHS use in England for adults with HER2-low advanced or metastatic breast cancer after prior treatment progression. - The decision follows a UK-US pharmaceutical pricing deal that raised NICE's cost-effectiveness threshold and a new quality-of-life assessment method. - Clinical trials showed Enhertu extended median overall survival to 23.4 months versus 16.8 months with standard chemotherapy, a 6.6-month gain. - About 1,000 patients a year in England are expected to be eligible, with Scotland already providing access since 2023 and 26 other European countries covering it.
- AstraZeneca will invest nearly 200 million yuan, about $29.8 million, to upgrade its new drug development and supply building at its Wuxi base in China. - The upgraded facility will support process development and production of an investigational cardiovascular drug and back its global supply after commercialization. - The project covers roughly 5,800 square meters, is scheduled to begin operations in the fourth quarter of 2029, and targets annual capacity of 400 million tablets. - Once complete, Wuxi is expected to become AstraZeneca's first Asia-Pacific facility capable of supporting global launch and supply of new drugs.
- NICE has reversed its 2024 rejection of Enhertu, allowing doctors in England to prescribe the drug for HER2-low metastatic breast cancer from Thursday. - Enhertu offers patients almost seven extra months of life on average, with some living up to three years longer, affecting about 1,000 women annually. - The reversal follows a UK-US trade deal raising medicine spending by 25% and NICE's QALY threshold increase from £30,000 to £35,000. - Charities welcomed access but noted thousands missed out during the two-year delay, with Breast Cancer Now calling for systemic reform.
- Pfizer withdrew its EU marketing authorization application for subcutaneous anti-PD-1 antibody Zumrad (sasanlimab) in BCG-naive, high-risk non-muscle invasive bladder cancer on 13 February 2026. - The EMA's CHMP provisionally concluded the drug could not be authorized, citing protocol changes during the pivotal CREST trial and a statistical analysis method altered to favor a positive result. - Regulators also flagged the unblinded investigator-assessed event-free survival endpoint as potentially biased and noted overall survival data did not support the primary finding.
- China's NMPA has granted Breakthrough Therapy Designation to SYS6010, CSPC's EGFR-targeted antibody-drug conjugate, for recurrent or metastatic AGA-negative non-squamous NSCLC after immunotherapy and platinum chemotherapy. - CSPC says the AGA-negative population represents roughly 40% of NSCLC cases in China and has limited options beyond single-agent chemotherapy after first-line failure. - SYS6010 pairs a humanised anti-EGFR antibody with a topoisomerase I inhibitor payload via a cleavable linker, and a randomised Phase III monotherapy trial in this setting is enrolling.
