相关临床试验
1
1 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
1993
进行中（未招募）
1
100.0%
- Galimedix Therapeutics successfully completed Phase 1 trials for oral GAL-101, triggering an undisclosed milestone payment from partner Théa Open Innovation. - The oral formulation demonstrated excellent safety, tolerability, and pharmacokinetic profile with effective blood-brain barrier penetration, supporting Phase 2 advancement in Alzheimer's disease. - GAL-101 targets misfolded amyloid beta monomers to prevent toxic oligomer formation, addressing a validated target in neurodegenerative diseases affecting both brain and retina. - The milestone payment provides operational runway for Galimedix to advance GAL-101 development in Alzheimer's disease while the eye drop formulation progresses in Phase 2 for geographic atrophy.
- Iolyx Therapeutics has entered a strategic partnership with Laboratoires Théa worth up to $280 million for the development and commercialization of ILYX-002 for autoimmune-associated dry eye disease. - Phase 2 clinical trial data demonstrated statistically significant improvement in corneal staining starting at day 15 in patients with challenging autoimmune conditions. - The company simultaneously raised $15 million in Series B funding led by Frazier Life Sciences to support pipeline expansion into retinal diseases. - Théa will assume primary responsibility for Phase 3 clinical trials and commercialization activities, while Iolyx retains design and manufacturing responsibilities.
- The UK's MHRA has issued a class 2 medicines recall for batch 4V64 of Zaditen 0.25 mg/ml eye drops solution due to a manufacturing event that may increase microbial contamination risk. - Approximately 11,360 packs of the affected batch were distributed starting January 27, 2025, with an expiration date of September 30, 2026. - Healthcare professionals must immediately stop supplying the batch and quarantine all remaining stock for return to suppliers. - No adverse events or product quality complaints have been reported to date, and the recall is being conducted as a precautionary measure.
- Kiora Pharmaceuticals has granted Senju Pharmaceutical an exclusive option for KIO-301 development and commercialization rights across key Asian markets including Japan and China, with a total potential deal value of $110 million plus royalties. - KIO-301 is a novel "molecular photoswitch" therapy currently in Phase 2 trials for inherited retinal diseases like retinitis pigmentosa, designed to restore light-sensing capabilities to retinal ganglion cells and potentially restore vision. - The partnership extends Kiora's global reach beyond its existing worldwide agreement with Théa Open Innovation, bringing the combined potential value of strategic partnerships to over $400 million.
• Novaliq and Laboratoires Théa secured European Commission approval for Vevizye (ciclosporin 0.1% eye drops) for moderate to severe dry eye disease. • Vevizye, utilizing Novaliq’s EyeSol technology, is the first water-free ciclosporin 0.1% eye drop approved in the EU for this condition. • Clinical trials (ESSENCE-1 and ESSENCE-2) demonstrated statistically significant reduction in corneal fluorescein staining with Vevizye treatment. • Laboratoires Théa will commercialize Vevizye in Europe and select MENA countries, expanding access to this innovative treatment.
