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ChromaDex (CDXC) FDA Events

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FDA Events for ChromaDex (CDXC)

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

ChromaDex's Drugs in FDA Review

Niagen - FDA Regulatory Timeline and Events

Niagen is a drug developed by ChromaDex for the following indication: Nicotinamide Riboside Chloride or NRC. 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.

nicotinamide adenine dinucleotide - FDA Regulatory Timeline and Events

nicotinamide adenine dinucleotide is a drug developed by ChromaDex for the following indication: for the Treatment of Ataxia Telangiectasia (AT). 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.

ChromaDex FDA Events - Frequently Asked Questions

In the past two years, ChromaDex (CDXC) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, ChromaDex (CDXC) has reported FDA regulatory activity for the following drugs: Niagen and nicotinamide adenine dinucleotide.

The most recent FDA-related event for ChromaDex occurred on September 10, 2024, involving Niagen. The update was categorized as "Provided Update," with the company reporting: "ChromaDex Corp. announce the second wave of intravenous (IV) wellness clinics that will offer pharmaceutical-grade Niagen® (nicotinamide riboside chloride or NRC), branded Niagen+, in intravenous (IV) and injectable forms."

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

  • Nicotinamide Riboside Chloride or NRC - Niagen
  • for the Treatment of Ataxia Telangiectasia (AT) - nicotinamide adenine dinucleotide

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:CDXC) was last updated on 7/12/2025 by MarketBeat.com Staff
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