Ipsen ((GB:0MH6)) announced an update on their ongoing clinical study.
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Study Overview: Ipsen’s clinical study, titled ‘Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD),’ aims to evaluate the long-term safety and effectiveness of Increlex® in treating SPIGFD. This study is significant as it seeks to provide comprehensive safety data over an extended period, crucial for understanding the treatment’s impact on young patients.
Intervention/Treatment: The study investigates Increlex®, a drug administered as a 10 mg/ml solution for injection. It is intended to treat children and adolescents with SPIGFD by supplementing insulin-like growth factor-1, which is deficient in these patients.
Study Design: This observational study employs a case-only model with both retrospective and prospective time perspectives. It is non-interventional and focuses on collecting data over a five-year period to assess the drug’s safety and effectiveness.
Study Timeline: The study began on April 30, 2009, and is currently recruiting participants. The last update was submitted on August 26, 2025, indicating ongoing data collection and analysis. The primary completion and estimated completion dates are not specified, reflecting the study’s open-ended nature.
Market Implications: The continuation and updates of this study could positively influence Ipsen’s stock performance by reinforcing investor confidence in the safety and effectiveness of Increlex®. As the study progresses, it may impact market dynamics, especially if competitors are developing similar treatments for SPIGFD.
The study is ongoing, with further details available on the ClinicalTrials portal.