相关临床试验
3
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
2005
进行中（未招募）
1
33.3%
已完成
2
66.7%
暂无批准数据
- Lipella Pharmaceuticals received U.S. Patent No. 12,326,492 for an MRI-based method to detect lesions in body cavities, specifically targeting interstitial cystitis diagnosis. - The patent provides protection through at least 2045 and covers technology that could enhance outcome assessments for mucosal disorders across Lipella's pipeline. - The diagnostic method utilizes a novel MRI contrast agent to non-invasively monitor lesion progression or regression in body cavities. - The technology could support Lipella's existing clinical programs including LP-310 for oral lichen planus, LP-10 for hemorrhagic cystitis, and LP-50 for bladder cancer.
- Lipella Pharmaceuticals has re-signed its manufacturing collaboration agreement with Cook MyoSite to support Chemistry, Manufacturing and Control documentation for clinical products LP-10 and LP-310. - LP-310 is a liposomal-tacrolimus oral rinse formulation being developed for oral lichen planus, a condition with no approved treatments currently available. - The company reported positive topline results from the second cohort (0.50 mg) of its Phase 2a multicenter, dose-ranging trial evaluating LP-310 in April. - This partnership supports late-stage development and scalable manufacturing as Lipella's clinical pipeline matures toward commercializable assets.
- Lipella Pharmaceuticals has completed enrollment in its Phase IIa trial evaluating LP-310, a liposomal tacrolimus oral rinse, for treating oral lichen planus across three dose cohorts at seven US trial sites. - Early data from lower dose cohorts shows promising safety and efficacy signals, with clinically meaningful reductions in pain, ulceration, and inflammation reported for this autoimmune condition with no FDA-approved therapies. - Topline results from the highest dose cohort (1.0mg) are expected in Q2 2024, with plans to submit an IND application for a Phase IIb trial in late 2025 and pursue potential breakthrough therapy designation.
- The FDA has approved an Expanded Access Program for LP-310, an innovative oral rinse therapy targeting oral lichen planus, a condition affecting 6 million Americans with no current FDA-approved treatments. - Lipella Pharmaceuticals' LP-310, currently in Phase 2a trials, is designed to provide targeted relief while minimizing systemic exposure in patients with this chronic inflammatory condition. - The expanded access approval marks a significant milestone in addressing the unmet medical need, allowing patients with serious conditions to access the treatment outside of clinical trials.
- A new report highlights the unmet need for targeted Lichen Planus (LP) treatments, as current options primarily offer palliative care. - The LP pipeline includes over three products in various stages of development, from preclinical to Phase II trials, indicating significant innovation. - Lipella Pharmaceuticals' LP-310, currently in Phase II trials for oral Lichen Planus (OLP), is a notable emerging therapy. - Companies like Incyte and AFYX Therapeutics are also advancing LP therapeutics, suggesting a competitive and evolving treatment landscape.
- Lipella Pharmaceuticals' LP-310, a liposomal-tacrolimus oral rinse, demonstrated statistically significant improvements in treating oral lichen planus (OLP). - The Phase 2a trial showed improvements in patient-reported and investigator-measured efficacy endpoints, with a strong safety profile and no serious adverse events. - LP-310 is the only oral rinse topical treatment in development for OLP, which affects approximately 6 million Americans and has no FDA-approved therapies. - Lipella plans to advance the trial, submit a Phase 2b clinical trial application, and request Breakthrough Therapy designation from the FDA in 2025.
- Lipella Pharmaceuticals completes the first cohort dosing in its Phase 2a trial of LP-310 for Oral Lichen Planus (OLP). - Initial results from the 0.25 mg dose cohort show promising tolerability and minimal systemic exposure of tacrolimus. - The trial advances to the next stage, evaluating a higher dose of 0.5 mg of LP-310, with top-line data expected by year-end. - LP-310 aims to address the unmet need for effective, well-tolerated treatments for OLP, impacting approximately 6 million Americans.
- Lipella Pharmaceuticals received U.S. Patent No. 12,138,345 for its liposomal drug delivery platform, enhancing targeted therapeutic agent delivery. - The patent protects Lipella's method using metastable liposomes, extending market exclusivity for LP-10 and LP-310, both in Phase 2 trials. - LP-10, a liposomal tacrolimus formulation, targets hemorrhagic cystitis, while LP-310, an oral rinse, addresses oral lichen planus. - With patents extending to 2035 in multiple countries, Lipella aims to advance its clinical pipeline and explore new therapeutic applications.
