Sponsor Overview
Explore verified public information about Abbisko Therapeutics Co., Ltd.'s expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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ClinicalTrials.gov data sources power this status.
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Expanded Access Intelligence
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Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria Abbisko aspires to discover and develop differentiated therapeutics for the treatment of cancer diseases. One of the Abbisko’s lead products, ABSK021, is an oral, potent, highly selective CSF-1R inhibitor. It is currently being investigated as a single agent in one Phase 3 clinical trial for the treatment of patients with TGCT (Tenosynovial Giant Cell Tumor). We are conducting clinical trials aiming at obtaining regulatory approval to make ABSK021 available to all patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access ABSK021 at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov.. Abbisko understands the interest of patients in accessing ABSK021 outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases, however we do not currently offer any Expanded Access Programs for ABSK021. Abbisko recognizes the need for Expanded Access Programs and will re-evaluate the status of our policy based on data from ongoing and future clinical trials.
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