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Cyclo Therapeutics (CYTH) FDA Events

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FDA Events for Cyclo Therapeutics (CYTH)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cyclo Therapeutics (CYTH). Over the past two years, Cyclo Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Trappsol and Trappsol®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cyclo Therapeutics' Drugs in FDA Review

Trappsol Cyclo (AD) - FDA Regulatory Timeline and Events

Trappsol Cyclo (AD) is a drug developed by Cyclo Therapeutics for the following indication: Alzheimer's Disease (AD). 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.

Trappsol® Cyclo™ - FDA Regulatory Timeline and Events

Trappsol® Cyclo™ is a drug developed by Cyclo Therapeutics for the following indication: For the treatment of Niemann-Pick Disease Type C1 (NPC1). 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.

Cyclo Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Cyclo Therapeutics (CYTH) has reported FDA regulatory activity for the following drugs: Trappsol® Cyclo™ and Trappsol Cyclo (AD).

The most recent FDA-related event for Cyclo Therapeutics occurred on June 18, 2025, involving Trappsol® Cyclo™. The update was categorized as "Provided Update," with the company reporting: "Rafael Holdings, Inc. that its subsidiary Cyclo Therapeutics' 96-week pivotal phase 3 TransportNPC study evaluating intravenous (IV) Trappsol® Cyclo™ for the potential treatment of Niemann-Pick Disease Type C1 (NPC1) will continue based on the independent Data Monitoring Committee (DMC) review of safety and efficacy data at the prespecified 48-week interim analysis."

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

  • For the treatment of Niemann-Pick Disease Type C1 (NPC1) - Trappsol® Cyclo™
  • Alzheimer's Disease (AD) - Trappsol Cyclo (AD)

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:CYTH) was last updated on 7/10/2025 by MarketBeat.com Staff
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