相关临床试验
2605
196 进行中
药物批准
98
批准总数
监管机构
3
监管机构数
成立时间
N/A
尚未招募
24
0.9%
No Longer Available
4
0.1%
终止
152
5.8%
招募中
82
3.1%
暂停
5
0.2%
Approved For Marketing
8
0.3%
撤回
40
1.5%
进行中（未招募）
172
6.6%
Unknown
2
0.1%
已完成
2116
81.2%
- The FDA has accepted for filing and granted Priority Review to LEO Pharma's NDA for dersimelagon in erythropoietic protoporphyria and X-linked protoporphyria, with a PDUFA date by end of February 2027. - LEO Pharma has closed its acquisition of worldwide dersimelagon rights from Tanabe Pharma for up to USD 435 million in upfront and near-term milestone payments plus tiered royalties. - Dersimelagon is an investigational once-daily oral small-molecule MC1R agonist that could become the first oral treatment for EPP and XLP if approved. - The Phase 3 INSPIRE study showed statistically significant and clinically meaningful results across primary and secondary endpoints, including prolonged daily sunlight exposure time to first prodromal symptoms.
- The FDA granted accelerated approval to Bayer's oral TKI Hyrnuo (sevabertinib) for first-line treatment of locally advanced or metastatic non-squamous HER2-mutant NSCLC. - The decision, announced September 9, 2026, followed Priority Review and Breakthrough Therapy Designation and expands a November 2025 approval limited to previously treated patients. - Approval rests on the Phase I/II SOHO-01 trial's 69 treatment-naive patients, where objective response rate reached 75% (95% CI: 64-85) with 6% complete responses. - Continued approval may depend on confirmatory Phase III SOHO-02 results, and the label carries warnings for diarrhea, hepatotoxicity, ILD/pneumonitis, ocular and cardiac toxicity.
- Oligomerix, a clinical-stage biotech, has appointed Cara Cassino, M.D., as Interim President and CEO to lead the company's transition from discovery to clinical-stage drug development. - Dr. Cassino brings 25 years of clinical development and commercialization experience, with over 25 FDA/EMA drug approvals and leadership roles at Boehringer Ingelheim, Pfizer, Forest Laboratories, and ContraFect Corp. - The company's lead compound OLX-07010, an oral once-daily tau-targeting small molecule, has completed a Phase 1a study demonstrating a favorable safety profile in healthy volunteers. - OLX-07010 has shown the ability to prevent tau protein accumulation in multiple animal models, positioning it as a potential therapeutic for Alzheimer's disease and related neurodegenerative disorders.
- The global DLL3 targeted therapies market is projected to exceed USD 2 billion by 2030, driven by advancing pipeline candidates and additional products approaching regulatory review. - Amgen holds a leading commercial position through Imdelltra, which reported revenue of more than USD 600 million in 2025, validating the commercial potential of DLL3-directed oncology treatment. - Combination therapy has emerged as a significant research focus, with Zai Lab and Amgen evaluating zocilurtatug pelitecan alongside Imdelltra, and Zai Lab partnering with Boehringer Ingelheim to study it with obrixtamig. - The United States is expected to remain the leading sales market, while China is anticipated to maintain a prominent position in DLL3 clinical research.
- Gubra initiated the Phase 1/2a trial of GUB-UCN2, advancing its internal R&D pipeline into clinical development during H1 2026. - Partnered obesity programs from AbbVie and Boehringer Ingelheim advanced to Phase 2, underscoring the value of Gubra's peptide discovery platform. - H1 2026 revenue fell to DKK 126.3 million from DKK 2,492.1 million a year earlier, reflecting a large one-time AbbVie deal in the prior-year period. - The company launched Gubra Ventures to accelerate innovation and value creation, with a first announcement expected soon.
- LEO Pharma has agreed to acquire worldwide rights to the investigational drug dersimelagon from Tanabe Pharma for up to $435 million in up-front and near-term milestone payments. - Dersimelagon is an oral, once-daily melanocortin-1 receptor (MC1R) agonist being developed for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), rare genetic disorders causing extreme sunlight sensitivity. - In Phase 3 INSPIRE trials, treated patients tolerated sunlight an average of 23 minutes longer before prodromal symptoms compared to placebo, and the FDA could approve the drug as early as 2027. - If approved, dersimelagon would become the first oral treatment for EPP and XLP, offering an alternative to the implant-based therapy Scenesse.
- Surrozen has submitted an Investigational New Drug (IND) application to the FDA for SZN-8141, a bifunctional Wnt agonist and VEGF antagonist antibody, for the treatment of diabetic macular edema (DME). - SZN-8141 combines Frizzled 4 (FZD4)-mediated Wnt agonism with VEGF antagonism, and in preclinical models demonstrated superior reductions in neovascularization and vascular leakage versus anti-VEGF monotherapy. - The DUET Phase 1b/2a trial is expected to initiate by year-end 2026, with initial data anticipated in the second half of 2027. - The U.S. Patent Trial and Appeal Board denied Merck's post-grant review petition, reinforcing Surrozen's intellectual property position on its Wnt-based platform.
- Nine pharmaceutical companies, including Lilly, Pfizer, and Novo Nordisk, now sell branded drugs directly to patients with discounts ranging from 55% to 80% off list price, bypassing PBMs and specialty pharmacies. - The IRA's drug price negotiation taking effect in 2026 and PBM extraction of 45–55% of list price have made DTP a commercial necessity rather than a goodwill gesture for specialty brands. - Well-run DTP programs capture 15–25% of a brand's total script volume by recovering patients lost to prior authorization denials, step therapy, and high out-of-pocket costs. - DTP is most effective in self-administered, recurring therapy areas like obesity, diabetes, and migraine, but structurally incompatible with oncology, rare disease, and infusion-based biologics.
- 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.
- The global NASH treatment market is projected to grow from USD 8.75 billion in 2025 to USD 46.87 billion by 2032, expanding at a CAGR of 27.1%. - Madrigal's Rezdiffra, approved in March 2024, created the first dedicated liver-directed prescription pathway for noncirrhotic NASH with moderate-to-advanced fibrosis. - Novo Nordisk's Wegovy gained FDA approval in August 2025 for MASH with F2–F3 fibrosis, connecting liver treatment to established obesity and diabetes care networks. - Late-stage pipeline candidates from Eli Lilly, Akero Therapeutics, 89bio, Inventiva, and Boehringer Ingelheim could create a multi-mechanism, segmented treatment market.
