SciSparc's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by SciSparc (SPRC).
Over the past two years, SciSparc has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SCI-110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SCI-110 FDA Regulatory Timeline and Events
SCI-110 is a drug developed by SciSparc for the following indication: For the treatment of Tourette Syndrome ("TS").
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SCI-110
- Announced Date:
- September 2, 2026
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that its subsidiary, NeuroThera Labs Inc announced that it is pursuing U.S. Food and Drug Administration ("FDA") Orphan Drug Designation covering SCI-110, its drug candidate for the treatment adults with Tourette Syndrome ("TS"), a rare condition that may qualify for Orphan Drug Designation.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- August 5, 2026
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced the initiation of NeuroThera’s Phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, New Haven, Connecticut, USA.
AI Summary
SciSparc Ltd. announced that NeuroThera’s Phase IIb clinical trial has begun at the Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut. The center is one of the study’s key clinical sites and will evaluate SCI-110 in adults with Tourette syndrome (TS).
SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single dosage form. The treatment is being developed to reduce tics and related symptoms in adults with TS, while also aiming to limit side effects. The trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel.
NeuroThera Labs, a clinical-stage pharmaceutical company, is developing therapies for central nervous system disorders and other underserved conditions. The Phase IIb study represents continued progress in evaluating SCI-110 across multiple international research centers.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- July 15, 2026
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd announced the initiation of its Phase IIb clinical trial site at Hannover Medical School, Hanover, Germany ("MHH"), for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults.
AI Summary
SciSparc Ltd. announced that it has opened a Phase IIb clinical trial site at Hannover Medical School in Hanover, Germany, for SCI-110, its cannabinoid-based treatment candidate for adults with Tourette Syndrome. The trial is also being conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. The company says this step moves the study forward as it works to test SCI-110 in multiple medical centers. SCI-110 is designed to address the needs of adults living with Tourette Syndrome, a condition that can cause repeated movements and vocal tics. SciSparc said the new site expands its clinical reach and supports its effort to gather data from an international patient group.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- September 30, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that the U.S. Food and Drug Administration ("FDA") has confirmed that its investigational new drug ("IND") application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome ("TS").
AI Summary
SciSparc Ltd. announced that the U.S. Food and Drug Administration (FDA) has confirmed its investigational new drug (IND) application for its first in class drug candidate SCI-110. This confirmation allows the company to move forward with Phase IIb clinical trials in the U.S. for adult patients suffering from Tourette Syndrome (TS). SCI-110 is designed to address the unmet medical need in TS treatment by offering a therapy with both higher efficacy and improved safety compared to current medications. The upcoming study will evaluate the drug’s effectiveness and safety over a period, focusing on the reduction of tic severity. This milestone marks an important step for SciSparc, as the company aims to provide patients with a treatment that can potentially manage a broader range of TS symptoms while ensuring a favorable safety profile.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- September 23, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that the U.S. Food and Drug Administration ("FDA") has confirmed that its investigational new drug ("IND") application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome ("TS").
AI Summary
SciSparc Ltd. announced that the U.S. Food and Drug Administration (FDA) has confirmed its investigational new drug (IND) application for the study of its first in class drug candidate, SCI-110, in adults with Tourette Syndrome (TS). With this clearance, the Phase IIb clinical trials can now proceed in the United States. These trials aim to evaluate the efficacy, safety, and tolerability of SCI-110 as a daily oral treatment in patients aged 18 to 65 years.
The FDA's swift confirmation of the IND application is a significant milestone for SciSparc. It demonstrates regulatory confidence in advancing SCI-110 for TS and supports the company’s commitment to developing innovative therapies for central nervous system disorders. This progress brings new hope for adults suffering from TS who require safe and effective treatment options.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- September 18, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that it has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome ("TS"), with its submission of an Investigational New Drug application to the U.S. Food
AI Summary
SciSparc Ltd. has taken a major step in its search for Tourette Syndrome treatments by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. This submission supports the upcoming Phase IIb clinical trial of its proprietary drug candidate, SCI-110, which is designed to treat TS symptoms in adult patients. The trial will be conducted at three renowned centers: Yale Child Study Center in the United States, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center in Israel, all of which have secured the necessary institutional and regulatory approvals. This move highlights SciSparc’s commitment to advancing research on central nervous system disorders and may pave the way for new, effective treatment options for individuals suffering from Tourette Syndrome.
Read Announcement
SciSparc FDA Events - Frequently Asked Questions
As of now, SciSparc (SPRC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, SciSparc (SPRC) has reported FDA regulatory activity for SCI-110.
The most recent FDA-related event for SciSparc occurred on September 2, 2026, involving SCI-110. The update was categorized as "Provided Update," with the company reporting: "SciSparc Ltd. announced that its subsidiary, NeuroThera Labs Inc announced that it is pursuing U.S. Food and Drug Administration ("FDA") Orphan Drug Designation covering SCI-110, its drug candidate for the treatment adults with Tourette Syndrome ("TS"), a rare condition that may qualify for Orphan Drug Designation."
Currently, SciSparc has one therapy (SCI-110) targeting the following condition: For the treatment of Tourette Syndrome ("TS")..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:SPRC last updated on 9/2/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
