相关临床试验
33
13 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
1999
进行中（未招募）
13
39.4%
已完成
17
51.5%
招募中
1
3.0%
终止
2
6.1%
- 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.
- The FDA has granted SCYNEXIS both Qualified Infectious Disease Product (QIDP) and Fast Track designations for SCY-247, a second-generation triterpenoid antifungal therapy targeting drug-resistant fungal infections. - SCY-247 demonstrated potent antifungal activity against challenging pathogens including Candida auris and echinocandin-resistant C. glabrata in preclinical studies, with Phase 1 data showing promising safety and pharmacokinetic properties. - The QIDP designation ensures at least 10 years of market exclusivity following approval, while Fast Track status enables accelerated development pathways including more frequent FDA meetings and rolling review eligibility. - SCYNEXIS plans to initiate Phase 1 IV formulation studies and Phase 2 oral formulation trials for invasive candidiasis in 2026, addressing the growing threat of multi-drug resistant fungal infections.
- SCYNEXIS has completed the transfer of BREXAFEMME's New Drug Application to GSK, allowing the pharmaceutical giant to initiate FDA discussions for the antifungal drug's relaunch. - BREXAFEMME (ibrexafungerp) is FDA-approved for treating vulvovaginal candidiasis and reducing recurrent infections, representing the first in SCYNEXIS's novel "fungerps" antifungal platform. - Following relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones plus low to mid single-digit royalties from GSK. - The transfer positions GSK to reintroduce BREXAFEMME for vulvovaginal candidiasis and refractory vulvovaginal candidiasis in the U.S. market through regulatory engagement with the FDA.
- SCYNEXIS announced federal funding for a five-year, $7 million annual grant supporting development of next-generation triterpenoid antifungals (fungerps) to combat resistant fungal infections. - The collaboration between Hackensack Meridian CDI and Johns Hopkins researchers aims to advance fungerp candidates from preclinical stage to IND-ready status with enhanced pharmacological properties. - With approximately four million annual deaths globally attributed to fungal infections, the NIH-funded initiative addresses a critical unmet medical need in antimicrobial resistance. - The triterpenoid antifungal class represents the first new antifungal compounds approved since 2001, with ibrexafungerp already FDA-approved for vulvovaginal candidiasis treatment.
- NanoNewron received a $2.5 million NIH STTR Phase 2 grant to advance its NN-840 program, a TNF-alpha inhibitor designed to cross the blood-brain barrier for Alzheimer's disease treatment. - The company's proprietary NewroBus™ technology enables therapeutic antibodies to cross the blood-brain barrier by targeting transferrin receptor 1 (TfR1) for efficient transcytosis. - The NN-840 compounds have demonstrated promising results in animal models with high TNF-alpha inhibition in the brain and excellent tolerability when administered subcutaneously. - The funding will support IND-enabling studies with an Investigational New Drug application submission expected next year, marking a significant milestone toward clinical trials.
- SCYNEXIS will present six studies at TIMM-12 demonstrating SCY-247's broad-spectrum antifungal activity against drug-resistant Candida auris, C. glabrata, and Aspergillus species. - SCY-247 showed consistently lower MICs against 65 FKS1-resistant C. auris isolates compared to echinocandins, including activity against pandrug-resistant strains from the New York-New Jersey area. - The second-generation triterpenoid antifungal demonstrated in vivo efficacy in mouse models, with dose-dependent reductions in kidney fungal burden for C. auris infections. - Phase 1 SAD/MAD trial results for oral SCY-247 are anticipated in Q3 2025, marking a key milestone for this novel antifungal platform.
- Iterum Therapeutics has appointed Christine Coyne as Chief Commercial Officer to lead the upcoming U.S. launch of ORLYNVAH, an FDA-approved oral antibiotic for uncomplicated urinary tract infections. - Coyne brings over 30 years of pharmaceutical commercial experience, including previous roles as Chief Commercial Officer at Innoviva and SCYNEXIS, with specific expertise in anti-infective portfolios. - ORLYNVAH represents a novel oral penem antibiotic targeting multi-drug resistant pathogens, including those with extended spectrum beta-lactamase resistance, addressing significant unmet medical needs. - The appointment comes at a pivotal time as Iterum prepares for commercial launch with partner EVERSANA, positioning the company for sustained growth in the anti-infective market.
