相关临床试验
60
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2000
进行中（未招募）
1
1.7%
Available
1
1.7%
已完成
46
76.7%
No Longer Available
1
1.7%
招募中
4
6.7%
终止
6
10.0%
撤回
1
1.7%
暂无批准数据
- Basilea received a $30 million non-dilutive funding tranche from BARDA after meeting a prespecified enrollment milestone in its dual Phase III fosmanogepix program. - Total BARDA commitments now reach $123 million under an agreement that could provide up to $268 million over 12 years if all extension options are exercised. - Fosmanogepix is a first-in-class antifungal targeting Gwt1 with activity against multidrug-resistant Candida auris and azole-resistant Aspergillus, with topline Phase III data expected in H1 2028. - Invasive candidiasis carries mortality rates as high as 40% despite existing therapy, underscoring the unmet need fosmanogepix aims to address.
- Nearly one in six laboratory-confirmed bacterial infections worldwide were resistant to antibiotic treatments in 2023, according to WHO data, signaling a worsening global antimicrobial resistance (AMR) crisis. - Resistance increased in more than 40% of monitored pathogen-antibiotic combinations between 2018 and 2023, with average annual increases of 5% to 15%, and bacterial AMR was associated with over 4.7 million deaths globally in 2021. - WHO warns that new antibiotic development is not progressing fast enough to replace medicines losing effectiveness, while the global antibiotic resistance market is projected to grow from USD 8.9 billion in 2025 to USD 16.55 billion by 2035. - Emerging strategies including phage therapy, artificial intelligence-driven drug discovery, vaccines, and the WHO Global Action Plan on Antimicrobial Resistance 2026–2036 aim to address the growing threat.
- The US invasive fungal infections market was valued at nearly USD 390 million in 2025 and is projected to expand significantly through 2036, driven by rising immunocompromised populations and novel antifungal launches. - Approximately 112,000 incident cases of invasive fungal infections occurred in the United States in 2025, with invasive candidiasis and invasive aspergillosis accounting for nearly 50% of the total disease burden. - Nearly 90% of patients eventually develop resistance to first-line antifungal therapy, while around 30% develop resistance to second-line agents, underscoring the urgent need for drugs with novel mechanisms of action. - Promising pipeline candidates including Fosmanogepix, Olorofim, SCY-247, and MAT2203 are advancing through clinical development, with SCY-247 receiving FDA QIDP and Fast Track designations in January 2026.
- Basilea Pharmaceutica and Phare Bio announced a strategic partnership to develop a novel broad-spectrum antibiotic using AI-driven drug discovery to address critical unmet needs for patients with life-threatening infections. - Phare Bio will deploy its generative AI platform to design molecules meeting pre-defined target product profiles, while Basilea assumes responsibility for subsequent development and clinical advancement. - The collaboration represents a new model for antibiotic innovation, combining cutting-edge AI technology with industrial expertise to address antimicrobial resistance and economic sustainability challenges. - This partnership marks the first time an AI drug discovery platform has been aligned with a committed industrial partner for antibiotic development, targeting high-priority gram-negative pathogens.
- Basilea Pharmaceutica received a $30 million milestone payment from Pfizer following strong European sales performance of the antifungal drug Cresemba (isavuconazole). - Global sales of Cresemba reached $652 million in the 12 months between July 2024 and June 2025, representing a 27% year-over-year growth. - The drug is approved in over 70 countries for treating life-threatening invasive mold infections including invasive aspergillosis and mucormycosis. - Cresemba has orphan drug designation in multiple regions and is available in both intravenous and oral formulations for various patient populations.
- Basilea Pharmaceutica has entered an exclusive licensing agreement with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a novel oral antibiotic combination targeting complicated urinary tract infections. - The drug demonstrates bactericidal activity against multidrug-resistant Enterobacterales pathogens and addresses a critical unmet need for oral treatment options in cUTI, which accounts for over 600,000 hospital admissions annually in the US. - Basilea plans to initiate a registrational Phase 3 clinical program within approximately 18 months, with the transaction potentially worth up to $325 million in milestone payments to Venatorx. - The antibiotic combination has received FDA Qualified Infectious Disease Product and Fast Track designations, positioning it as a promising solution for treating infections caused by extended-spectrum beta-lactamase producing bacteria.
- Basilea Pharmaceutica has initiated FORWARD-IM, a phase 3 registrational study evaluating fosmanogepix for treating invasive mold infections in adults, with completion expected in Q1 2028. - Fosmanogepix is a first-in-class broad-spectrum antifungal with novel mechanism of action, showing activity against multidrug-resistant molds including Aspergillus, Fusarium, and Mucorales fungi. - The study will enroll approximately 220 patients across two cohorts, with the first cohort randomizing 160 patients 2:1 to fosmanogepix versus standard-of-care therapy. - This marks the second phase 3 study for fosmanogepix, following the FAST-IC trial initiated in September 2024 for candidemia and invasive candidiasis treatment.
- Basilea Pharmaceutica received $39 million in additional BARDA funding to continue development of novel antifungals fosmanogepix and BAL2062, bringing total committed funding to $68 million under a potential $268 million agreement. - The funding will support ongoing Phase 3 trials for fosmanogepix in yeast infections and an upcoming Phase 3 study in mold infections, plus preparation for Phase 2 trials of BAL2062. - Both antifungal candidates feature novel mechanisms of action and target life-threatening infections in immunocompromised patients, addressing critical unmet medical needs in treating drug-resistant fungal infections. - Fosmanogepix has demonstrated activity against multi-drug-resistant strains including Candida auris and rare difficult-to-treat molds, while BAL2062 shows fungicidal activity against azole-resistant Aspergillus species.
- Basilea Pharmaceutica received a second $2.5 million milestone payment in 2025 from partner Pfizer following strong Cresemba sales performance in Asia Pacific and China. - Global sales of Cresemba reached $562 million in 2024, representing 19% year-over-year growth and making it the world's largest branded antifungal for invasive fungal infections. - The antifungal drug is now marketed in more than 70 countries, with particularly robust uptake in China driving continued commercial success. - Cresemba is approved for treating invasive aspergillosis and invasive mucormycosis in adult patients across multiple regions including China, Europe, and the United States.
- Basilea Pharmaceutica's Zevtera (ceftobiprole) receives FDA approval for three indications, becoming the first beta-lactam antibiotic approved for Staphylococcus aureus bacteremia. - The approval addresses a significant medical need, with approximately 120,000 S. aureus bloodstream infections occurring annually in the US according to CDC data. - The drug's approval includes coverage for antimicrobial-resistant infections, particularly MRSA, targeting a market projected to reach $5.5 billion by 2030.
