相关临床试验
2605
196 进行中
药物批准
101
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.
- Agomab reported positive Phase 1 results for inhaled AGMB-447 in 10 patients with idiopathic pulmonary fibrosis, showing proof of TGF-beta/ALK5 inhibition in the lungs. - At 4.5 mg twice daily for 14 days, lung concentrations remained high enough to inhibit ALK5 while systemic exposure stayed low, and pSMAD3 fell by more than 50%. - The 4.5 mg dose was generally well tolerated, with cough and bronchospasm the most common adverse events and more events reported at 6 mg. - The Phase 2 INSPIRIA study will randomize about 120 IPF patients 2:1 to AGMB-447 4 mg twice daily or placebo on top of standard of care, starting in the second half of 2026.
- The FDA expanded the indication for Bayer's sevabertinib, marketed as Hyrnuo, to include first-line treatment of HER2-mutated non-small cell lung cancer. - In the SOHO-01 trial, Hyrnuo produced a 75% objective response rate among 69 previously untreated patients with locally advanced or metastatic HER2-mutated NSCLC. - Responses lasted at least 6 months in 73% of responders and at least 12 months in 38%, with 6% complete and 70% partial responses. - The approval remains accelerated, and the phase 3 SOHO-02 trial is comparing Hyrnuo with standard treatment in previously untreated advanced HER2-mutated NSCLC.
- 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.
