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Oct 23, 2026Regulatory decision

SciSparc's NeuroThera completes drug batch release for Tourette Phase IIb trial

NeuroThera Labs secured European regulatory sign-off on trial material, moving its SCI-110 Phase IIb study for Tourette Syndrome closer to patient enrollment.

SciSparc Ltd. (Nasdaq: SPRC) said on October 22, 2026 that its subsidiary NeuroThera Labs Inc. (TSXV: NTLX) made further progress in its FDA-approved clinical trial program testing SCI-110 for Tourette Syndrome in adults, according to a press release filed with the SEC.

NeuroThera finished manufacturing the investigational drug and received batch release certification from a European Qualified Person, a regulatory step that clears the material for shipment to study sites.1 The company said this release allows site activation work to proceed and supports the start of patient enrollment in the Phase IIb trial.1

The trial is running at three sites: Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut; Hannover Medical School in Hanover, Germany; and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.1 All three sites have finished their initiation activities and are ready to receive drug supplies once the QP batch release takes effect.1

SciSparc described the combination of completed site initiation and the European QP release as a significant operational milestone for NeuroThera as it moves toward patient enrollment, with shipments of investigational product to study sites expected soon.1

SCI-110 is described as NeuroThera's proprietary, patent-protected cannabinoid drug that combines dronabinol and palmitoylethanolamide, or PEA, into one oral dosage form.1 The Phase IIb study is designed to assess the drug's efficacy, safety and tolerability in adults with Tourette Syndrome.1

SciSparc, through its majority-owned subsidiary NeuroThera, is also developing SCI-110 for Alzheimer's disease and agitation, and SCI-210 for autism spectrum disorder and status epilepticus.1 Through NeuroThera, the company additionally holds a controlling interest in a business that sells hemp seed oil products on Amazon's marketplace.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.