Sponsor Overview
Explore verified public information about Neuraptive Therapeutics, Inc.'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.
Unique references curated across 2 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 1 supporting sources.
“Neuraptive considers requests for expanded access on a case-by-case basis. This approach preserves FDA oversight of expanded access, patient safety, and the integrity of clinical trials.”
Active EAPs on ClinicalTrials.gov
Score contribution: 60 — 1 supporting sources.
Conditions: Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria At Neuraptive, we are committed to developing first-in-class treatments for patients with peripheral nerve injuries (PNI) and physicians who treat them. NTX-001 has been designed and is being developed as an adjunctive treatment for patients with nerve injuries and may restore and improve the recovery of neurons following nerve repair surgery. We will be conducting clinical studies to demonstrate the safety and efficacy of NTX-001, and to obtain regulatory approval and ultimately make NTX-001 available. Before regulatory approval by the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities, patients gain access to investigational treatments, such as NTX-001, by participating in clinical trials and by ‘Expanded access,’ also referred to as compassionate use, ‘Early Access,’ and ‘Emergency Use’. Patients who seek access to investigational medicines outside of an established clinical study and before health authority marketing authorization may wish to do so because standard treatments have failed, because they cannot tolerate already approved medicines, because they are unable to participate in a clinical study or because there are no comparable or satisfactory therapy options available outside of clinical trials. The primary purpose of expanded access is to use the investigational drug for patient treatment purposes rather than to gather data on safety, tolerability, and effectiveness. If you have questions about Neuraptive’s expanded access policy, please contact Neuraptive at info@Neuraptive.com . Please expect a response within five business days.
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