相关临床试验
17
17 进行中
药物批准
24
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
16
94.1%
尚未招募
1
5.9%
- The Waldenström macroglobulinemia treatment market across the 7MM is expected to grow steadily through 2036, driven by rising diagnosis rates, aging populations, and adoption of targeted therapies. - Emerging agents including nemtabrutinib, bexobrutideg (NX-5948), and iopofosine I-131 aim to address relapsed/refractory disease and overcome resistance to covalent BTK inhibitors. - Cellectar's iopofosine I-131 achieved an 83.6% overall response rate and 61.8% major response rate in the Phase IIb CLOVER-WaM trial, with a median duration of response of 17.8 months. - The United States accounted for the largest Waldenström macroglobulinemia treatment market share in the 7MM in 2025, with an incidence of roughly 3 cases per million annually.
- Brazil's Anvisa authorized amendments and new clinical trial dossiers for 14 investigational drugs via Resolution-RE No. 2,602, published July 1, 2026. - Approved changes include protocol amendments for pembrolizumab (Merck), volrustomig (AstraZeneca), and sacituzumab govitecan (Gilead), alongside new trial dossiers for trontinemab (Roche) and nerandomilast (Boehringer Ingelheim). - The regulatory actions span oncology, infectious disease, inflammatory conditions, and reformulations of established drugs such as ibuprofen. - Companies may now implement approved modifications immediately, advancing these candidates toward eventual registration and potential commercialization in Brazil.
- Two recent Nature portfolio publications highlight the growing role of machine learning and deep learning in predicting drug–target binding affinities and drug–drug interactions, addressing critical challenges in pharmaceutical R&D. - Sequence-based computational models are demonstrating improved accuracy in forecasting how drug compounds interact with biological targets, potentially accelerating early-stage drug discovery. - Deep learning frameworks for drug–drug interaction prediction offer new tools to identify adverse combination effects before clinical exposure, enhancing patient safety. - These computational approaches represent a shift toward data-driven, predictive pharmacology that may reduce reliance on costly and time-intensive experimental screening.
- Sun Pharmaceutical Industries, India's largest drugmaker, is evaluating the acquisition of US-based Organon for approximately $10 billion, marking what would be the largest cross-border pharmaceutical acquisition in Indian history. - The potential deal would give Sun Pharma significant access to women's health products and biosimilars, including Organon's top-selling contraceptive Nexplanon and a robust biosimilar pipeline worth $660 million in annual sales. - Organon, spun out from Merck in 2021 with $9.5 billion in inherited debt, has faced financial challenges and leadership changes, making it an attractive turnaround opportunity for Sun Pharma's proven acquisition strategy.
- DelveInsight's 2025 pipeline report reveals a robust schizophrenia drug development landscape with over 55 companies advancing 60+ therapeutic candidates across various clinical stages. - Recent Phase III trials include Bristol-Myers Squibb's KarXT study in Japanese patients and Karuna Therapeutics' long-term safety extension study for adjunctive treatment. - Emerging therapies feature novel mechanisms including TAAR1 agonists, selective M4 receptor modulators, and CNS-penetrant sGC stimulators targeting unmet medical needs. - The pipeline spans multiple administration routes and molecule types, with promising candidates like Ulotaront, Emraclidine, and KarXT addressing the chronic mental disorder affecting 1% of the global population.
- DelveInsight's 2025 pipeline report reveals over 10 companies developing more than 10 therapies specifically targeting brain metastasis from breast cancer, addressing a critical unmet medical need. - ANG1005, a peptide-drug conjugate from Angiochem, has advanced to Phase III trials by targeting the blood-brain barrier through LRP-1 receptors to deliver paclitaxel directly to brain tumors. - Stemline Therapeutics announced a Phase 1b study combining elacestrant with abemaciclib for patients with brain metastases from ER-positive, HER2-negative breast cancer. - Brain metastases occur in 10-16% of metastatic breast cancer patients and are associated with poor prognosis, particularly affecting younger patients with ER-negative or HER2-positive tumors.
- The USPTO's Patent Trial and Appeal Board has instituted seven post-grant reviews challenging Halozyme's patents related to modified PH20 hyaluronidase polypeptides used in Merck's recently approved Keytruda Qlex. - Merck filed 14 patent challenges beginning in November 2024, alleging that Halozyme's patents are invalid due to obviousness, lack of written description, and enablement failures. - The patent dispute centers on modified polypeptides that exhibit increased stability and activity, with concurrent litigation ongoing in New Jersey federal court. - Keytruda Qlex, combining pembrolizumab and berahyaluronidase alfa-pmph, received FDA approval in September 2025, though sales data remains unavailable.
- AIM ImmunoTech has secured a Japanese patent covering Ampligen (rintatolimod) in combination with checkpoint inhibitors for cancer treatment, valid until December 20, 2039. - The patent encompasses multiple cancer types including pancreatic, ovarian, breast, lung, and colorectal cancers, strengthening AIM's intellectual property portfolio in Japan's third-largest global pharmaceutical market. - AIM is currently conducting Phase 2 trials combining Ampligen with checkpoint inhibitors, including a collaboration with AstraZeneca for metastatic pancreatic cancer showing promising survival benefits. - The company believes this novel combination approach could revolutionize treatment for historically challenging cancers through synergistic therapeutic effects.
- DelveInsight's 2025 report reveals over 165 companies are developing 170+ pipeline therapies for triple-negative breast cancer, driven by rising disease prevalence and growing research investments. - Recent clinical milestones include Cardiff Oncology's positive Phase 1b data for onvansertib plus paclitaxel, Akeso's breakthrough therapy designation for ivonescimab combination, and multiple Phase III studies initiated by AstraZeneca and others. - Leading pipeline candidates include trilaciclib (G1 Therapeutics), olaparib (AstraZeneca), and patritumab deruxtecan (Daiichi Sankyo/Merck), representing diverse therapeutic approaches from CDK4/6 inhibitors to antibody-drug conjugates. - The TNBC therapeutics market is expected to undergo substantial growth due to improved diagnostics, increased awareness, higher healthcare spending, and anticipated launches of innovative treatments.
- DelveInsight's 2025 pipeline analysis reveals 25+ companies developing 28+ therapies for gastrointestinal stromal tumors, indicating strong industry investment in this rare cancer space. - Merck Sharp & Dohme initiated a belzutifan monotherapy study in August 2025 for advanced wild-type GIST and other rare tumors, with objective response rate as the primary endpoint. - Key pipeline candidates include famitinib in Phase III development by Jiangsu Hengrui Medicine and novel approaches like Daiichi Sankyo's first-in-class GPR20-targeting ADC DS-6157. - Theseus Pharmaceuticals' THE-630 represents a promising pan-variant KIT inhibitor designed to overcome resistance mutations that limit current GIST therapies.
