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Incannex Healthcare (IXHL) FDA Approvals

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Incannex Healthcare's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Incannex Healthcare (IXHL). Over the past two years, Incannex Healthcare has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CannQuit-N, CannQuit-O, IHL-42X, and PSX-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

CannQuit-N FDA Regulatory Events

CannQuit-N is a drug developed by Incannex Healthcare for the following indication: for tobacco smoking cessation and control of relapse. 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.

CannQuit-O FDA Regulatory Events

CannQuit-O is a drug developed by Incannex Healthcare for the following indication: for the treatment of opioid use disorder (OUD). 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.

IHL-42X FDA Regulatory Timeline and Events

IHL-42X is a drug developed by Incannex Healthcare for the following indication: Obstructive Sleep Apnoea (OSA). 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.

PSX-001 FDA Regulatory Events

PSX-001 is a drug developed by Incannex Healthcare for the following indication: In Patients with Generalised Anxiety Disorder to Proceed. 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.

Incannex Healthcare FDA Events - Frequently Asked Questions

In the past two years, Incannex Healthcare (IXHL) 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, Incannex Healthcare (IXHL) has reported FDA regulatory activity for the following drugs: IHL-42X, PSX-001, CannQuit-O and CannQuit-N.

The most recent FDA-related event for Incannex Healthcare occurred on July 30, 2025, involving IHL-42X. The update was categorized as "Top-line results," with the company reporting: "Incannex Healthcare Inc is excited to share positive topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep apnoea (OSA). With over 900 million people affected globally and no approved oral pharmaceutical treatments currently available, IHL-42X's robust efficacy and exceptional safety profile position it as a potential transformative therapy for OSA patients worldwide."

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

  • Obstructive Sleep Apnoea (OSA) - IHL-42X
  • In Patients with Generalised Anxiety Disorder to Proceed - PSX-001
  • for the treatment of opioid use disorder (OUD). - CannQuit-O
  • for tobacco smoking cessation and control of relapse. - CannQuit-N

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:IXHL) was last updated on 8/2/2025 by MarketBeat.com Staff
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