Clinical Trials
31
2 active
Approvals
7
Total approvals
Agencies
3
Regulatory bodies
Founded
N/A
Active, not recruiting
2
6.5%
Completed
11
35.5%
Recruiting
8
25.8%
- Astellas has dosed the first patient in a Phase 3 trial of ASP2138, a subcutaneously administered bispecific antibody targeting CLDN18.2 and CD3-positive T cells, in first-line advanced gastric/GEJ cancer. - The randomized, double-blind, placebo-controlled study will enroll 570 participants and evaluates ASP2138 plus chemotherapy and pembrolizumab against placebo plus chemotherapy with or without pembrolizumab. - Co-primary endpoints are overall survival and progression-free survival, with the trial aiming to break the 6-to-7-month median progression-free survival ceiling of current standard-of-care regimens. - ASP2138 represents a mechanistically distinct T-cell engager approach layered onto Astellas' approved CLDN18.2 antibody zolbetuximab, supporting the company's goal of initiating five or more Phase 3 studies by fiscal year 2027.
- Autobahn Labs, a venture studio focused on transforming academic science into drug discovery programs, has announced a strategic partnership with global pharmaceutical company Astellas Pharma Inc. - The collaboration provides Astellas exclusive investment opportunities in selected drug discovery programs from Autobahn's translational research pipeline, which includes early-stage discoveries from leading academic institutions. - Selected research programs will be advanced through newly formed Program Companies with shared equity interests among Autobahn, Astellas, academic institutions, and founding investigators. - Astellas will receive a right of first negotiation for exclusive licenses to further develop and commercialize intellectual property arising from jointly funded programs.
- A US court has permitted Lupin Ltd. and Zydus Lifesciences Ltd. to expand their patent argument scope in their defense against Astellas Pharma's Myrbetriq patent litigation. - The companies launched generic versions of Myrbetriq (mirabegron) "at risk" in April 2025 despite ongoing litigation over the overactive bladder treatment worth $2.4 billion in combined market size. - The expanded argument scope provides both companies with additional ammunition to defend their at-risk launch and reduces their financial penalty risk in the patent dispute. - Astellas previously won a court ruling in April 2025 that blocked the generic manufacturers from selling their copycat versions of the overactive bladder medication.
- Astellas will showcase 16 abstracts at the 2025 ASCO Annual Meeting, including two oral presentations highlighting long-term survival data for its oncology portfolio. - New post-hoc analyses will feature five-year overall survival data for XTANDI (enzalutamide) in metastatic hormone-sensitive prostate cancer and exploratory analyses for PADCEV (enfortumab vedotin) in urothelial cancer. - The presentations underscore Astellas' commitment to delivering meaningful clinical outcomes for patients with advanced prostate and bladder cancers through innovative treatment approaches.
- Astellas Pharma has submitted a New Drug Application to Japan's MHLW for avacincaptad pegol, potentially becoming the first approved treatment for geographic atrophy in Japan. - The submission is supported by GATHER1 and GATHER2 clinical trials, which demonstrated the drug's ability to slow GA lesion growth with a favorable safety profile over two years. - Geographic atrophy affects over 5 million people globally, with 66% at risk of becoming legally blind without treatment, highlighting the significant unmet medical need.
- China's NMPA has approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer (la/mUC). - The approval is based on the EV-302 trial, which showed the combination significantly improved overall and progression-free survival compared to platinum-based chemotherapy. - The combination represents the first non-platinum treatment option for Chinese patients with advanced urothelial cancer in the first-line setting. - This approval marks a significant advancement in the treatment landscape, offering hope for longer survival to Chinese patients with advanced urothelial carcinoma.
- China's NMPA has approved zolbetuximab (VYLOY™) for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. - Zolbetuximab is the first monoclonal antibody approved in China that targets the CLDN18.2 biomarker expressed in gastric tumor cells. - Approval was based on Phase 3 GLOW and SPOTLIGHT trials, showing statistically significant improvements in progression-free and overall survival. - Approximately 35% of Chinese patients with advanced gastric and GEJ cancers have tumors expressing the CLDN18.2 biomarker.
- The FDA issued a Complete Response Letter for Astellas' IZERVAY (avacincaptad pegol) due to a statistical matter regarding proposed labeling language, unrelated to safety or efficacy. - Aldeyra Therapeutics' resubmitted New Drug Application (NDA) for reproxalap, a topical ocular treatment for dry eye disease, has been accepted by the FDA. - Aldeyra Therapeutics is expanding its option agreement with AbbVie, providing additional funding to support the commercialization of reproxalap for dry eye.
- The FDA issued a Complete Response Letter (CRL) for Astellas' supplemental New Drug Application (sNDA) for Izervay on November 15. - The CRL does not raise concerns regarding the safety, efficacy, or risk profile of Izervay, according to Astellas. - The FDA's decision is related to a statistical matter pertaining to the proposed labeling language for the product. - Astellas plans to seek clarification from the FDA and work towards addressing the agency's feedback to advance solutions for geographic atrophy.
• The FDA has approved Vyloy (zolbetuximab), a CLDN18.2-targeting monoclonal antibody, marking the first therapy of its kind approved in the U.S. • Vyloy is indicated for the treatment of adults with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. • The approval provides a new targeted treatment option for patients with gastric cancer, addressing a significant unmet medical need in this patient population.
