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Clinical Trial News

SSY Group Receives Approval for Compound Sodium Acetate and Glucose Injection in China

  • SSY Group has secured approval from China's National Medical Products Administration for its Compound Sodium Acetate and Glucose Injection.
  • The drug is classified as a type 3 chemical drug and has passed consistency evaluation, placing SSY Group among the first manufacturers in China with this approval.
  • The injection is designed to replenish and maintain water and electrolytes, as well as provide energy when oral administration is not feasible.
  • This approval marks a significant advancement in SSY Group's business development, offering a new treatment option for patients requiring intravenous hydration and electrolyte balance.

Advances in HIV Treatment: From Novel Prevention to Potential Cures

  • A novel nanomedicine using siRNAs targeting CCR5 and Nef shows promise in preventing HIV sexual transmission by blocking viral entry and reactivating autophagy.
  • An HIV-virus-like particle (HLP) therapeutic can reactivate dormant HIV in immune cells, making them susceptible to cART and the immune system, potentially curing HIV.
  • Despite advancements, challenges remain in HIV management, including global disparities in treatment access, drug resistance, and the virus's ability to establish latent reservoirs.

FDA Approves Rystiggo (rozanolixizumab-noli) for Generalized Myasthenia Gravis

  • The FDA has approved Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adults with specific antibody-positive subtypes.
  • Rystiggo, a humanized IgG4 monoclonal antibody, reduces circulating IgG levels by binding to the neonatal Fc receptor (FcRN).
  • Clinical trials demonstrated statistically significant improvements in MG-ADL and QMG scores with Rystiggo compared to placebo.
  • The most common adverse reactions reported were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

NCT05681715CompletedPhase 3
UCB Biopharma SRL
Posted 4/17/2023

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

NCT03971422CompletedPhase 3
UCB Biopharma SRL
Posted 6/3/2019

Alpheus Medical's Sonodynamic Therapy Shows Promise in Recurrent High-Grade Gliomas

  • Alpheus Medical announced positive Phase 1/2 trial results for its sonodynamic therapy (SDT) in recurrent high-grade gliomas, demonstrating a strong safety profile.
  • The trial showed extended median overall survival (15.7 months) and progression-free survival (5.5 months) compared to historical data for this aggressive brain cancer.
  • Alpheus's SDT combines low-intensity ultrasound with oral 5-aminolevulinic acid, offering a non-invasive treatment option that can be administered in an outpatient setting.
  • A randomized, controlled trial is planned for 2025 to further evaluate the efficacy of Alpheus Medical's SDT platform in treating recurrent high-grade gliomas.

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma

NCT05362409CompletedPhase 1
Alpheus Medical, Inc.
Posted 6/29/2022

Avapritinib Approved for Advanced Systemic Mastocytosis, Offering New Hope to Patients

  • Avapritinib, a novel drug, has been approved for treating advanced systemic mastocytosis (ASM) by the UK's NICE.
  • Clinical trials demonstrated that Avapritinib cleared the disease in a third of patients and significantly improved symptoms in almost all others.
  • The once-daily pill targets the KIT mutation in bone marrow cells, which drives the cancer, leading to improved quality of life and survival.
  • This approval marks a significant advancement in treating ASM, a rare and deadly blood cancer with limited treatment options.

Neurotech International's NTI164 Shows Promise in Pediatric Neurological Disorders

  • Neurotech International is progressing with trials of NTI164, a drug targeting pediatric neurological disorders, showing potential in improving neural network function.
  • The drug aims to modulate neuroinflammation and enhance neuroprotection, addressing critical unmet needs in conditions like Autism Spectrum Disorder and Cerebral Palsy.
  • Clinical trials are underway to evaluate NTI164's efficacy in improving cognitive and motor functions, with initial data suggesting positive trends in treated patients.

Vitamin D3 Dosage Trial in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

  • A clinical trial is underway to compare the effects of two different doses of vitamin D3 in critically ill patients receiving continuous renal replacement therapy (CRRT).
  • The study involves multiple visits over approximately 90-104 days to assess patient outcomes and monitor for adverse events.
  • Data management protocols ensure patient confidentiality and compliance with regulatory standards, including secure handling of electronic case report forms (eCRFs).
  • The trial aims to enhance participant retention through detailed information and flexible follow-up, with provisions for data handling in case of withdrawal.

Recce Pharmaceuticals Anticipates Key Clinical Trial Milestones for R327 Topical Gel

  • Recce Pharmaceuticals expects completion of its Phase II ABSSSI trial by the end of the year, with early results showing positive outcomes in treated patients.
  • Ethics approval has been granted to initiate a Phase III trial of R327G for Diabetic Foot Infections in Indonesia, commencing in mid-December.
  • Successful results from the Indonesia trial could lead to regulatory approval and commercial launch in the ASEAN region by the first half of 2026.
  • The ABSSSI market is projected to reach US$26 billion by 2032, highlighting the significant commercial potential of Recce's R327G.

Vorasidenib Shows Sustained Benefit in IDH-Mutant Low-Grade Glioma

  • Vorasidenib demonstrates a significant and sustained improvement in progression-free survival (PFS) compared to placebo in adults with IDH-mutant low-grade glioma.
  • The median time to next intervention (TTNI) was significantly longer with vorasidenib, indicating a durable treatment effect and delaying the need for subsequent therapies.
  • Updated results from a phase I study suggest vorasidenib and ivosidenib show promising activity in diffuse IDH1-mutant glioma, with vorasidenib demonstrating a higher response rate.
  • Vorasidenib's manageable safety profile and ability to reduce tumor volume, even after crossover from placebo, further support its role in treating IDH-mutant low-grade glioma.

Study of AG-120 and AG-881 in Subjects With Low Grade Glioma

NCT03343197CompletedPhase 1
Institut de Recherches Internationales Servier
Posted 3/20/2018

Vorasidenib Approved in China's Boao Lecheng for IDH-Mutant Glioma Treatment

  • Vorasidenib, a dual inhibitor of IDH1 and IDH2, has been approved for clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China.
  • This approval allows Chinese patients with IDH-mutant diffuse glioma access to the first-in-class targeted therapy before its official registration in China.
  • A real-world study is underway in Boao Lecheng to assess the safety and efficacy of Vorasidenib in Chinese patients, potentially accelerating research by 1-2 years.
  • Vorasidenib has already been approved in the US, Canada, Australia, Israel, Switzerland and UAE, marking its global recognition as an important treatment option.

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