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SciSparc (SPRC) FDA Events

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FDA Events for SciSparc (SPRC)

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 Ibogaine and SCI-110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SciSparc's Drugs in FDA Review

Ibogaine - FDA Regulatory Timeline and Events

Ibogaine is a drug developed by SciSparc for the following indication: For Pioneering Ibogaine Combination Therapy. 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.

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.

SciSparc FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, SciSparc (SPRC) has reported FDA regulatory activity for the following drugs: SCI-110 and Ibogaine.

The most recent FDA-related event for SciSparc occurred on September 30, 2024, involving SCI-110. The update was categorized as "study may proceed," with the company reporting: "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")."

Current therapies from SciSparc in review with the FDA target conditions such as:

  • For the treatment of Tourette Syndrome ("TS"). - SCI-110
  • For Pioneering Ibogaine Combination Therapy - Ibogaine

More FDA Event Resources from MarketBeat

  • 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

This page (NASDAQ:SPRC) was last updated on 7/11/2025 by MarketBeat.com Staff
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