PeptideTreatments
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Taltirelin: Research & Evidence

Established Evidence

Published research, clinical trial data, and evidence grading for Taltirelin across studied indications.

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Research Summary

Taltirelin has approximately 45 human studies and 3-5 RCTs from Japan, leading to PMDA approval as Ceredist in 2000 for spinocerebellar degeneration. The Kanazawa 1997 Phase 2 trial (PMID: 9278234, n=46) showed improved ataxia scores vs. placebo. Kinoshita 2024 (PMID: 39428104, n=85) confirmed continued safety and efficacy in a recent RCT. However, taltirelin is NOT FDA approved and is not available in the US or EU. No US-based clinical trials have been conducted. The US market for rare neurological conditions like spinocerebellar ataxia is small, and no company has pursued FDA approval.

Evidence by Indication (2 indications)

Indication Tier Trials Summary
Spinocerebellar ataxia Tier B 4 Multiple Japanese RCTs; PMDA approved (Ceredist); modest motor improvement
Cerebellar degeneration (other) Tier C 1 Limited data outside primary spinocerebellar indication

Graded using our evidence tier methodology.

Research Gap Score /10

Higher score = larger gap between therapeutic potential and available clinical evidence.

Citations (2 sources)

  1. 1. A placebo-controlled study of taltirelin in patients with spinocerebellar degeneration Clinical Trial

    Kanazawa I, et al. (1997), Journal of Neurology

  2. 2. Randomized, double-blind, placebo-controlled trial of taltirelin in spinocerebellar degeneration Clinical Trial

    Kinoshita M, et al. (2024), Neurological Sciences