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Jaguar Animal Health (JAGX) FDA Events

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FDA Events for Jaguar Animal Health (JAGX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Jaguar Animal Health (JAGX). Over the past two years, Jaguar Animal Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Canalevia-CA1, Crofelemer, Crofelemer, Gelclair, NP300, and NP-300. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Jaguar Animal Health's Drugs in FDA Review

Canalevia-CA1 - FDA Regulatory Timeline and Events

Canalevia-CA1 is a drug developed by Jaguar Animal Health for the following indication: For the treatment of chemotherapy-induced diarrhea (CID) in dogs. 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.

Crofelemer - FDA Regulatory Timeline and Events

Crofelemer is a drug developed by Jaguar Animal Health for the following indication: Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder. 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.

Crofelemer (SBS) - FDA Regulatory Timeline and Events

Crofelemer (SBS) is a drug developed by Jaguar Animal Health for the following indication: Short Bowel Syndrome. 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.

Gelclair - FDA Regulatory Timeline and Events

Gelclair is a drug developed by Jaguar Animal Health for the following indication: For oral mucositis. 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.

NP300 - FDA Regulatory Timeline and Events

NP300 is a drug developed by Jaguar Animal Health for the following indication: For Treatment of General Diarrhea in Dogs. 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.

NP-300 - FDA Regulatory Timeline and Events

NP-300 is a drug developed by Jaguar Animal Health for the following indication: Symptomatic Relief of Diarrhea from Cholera. 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.

Jaguar Animal Health FDA Events - Frequently Asked Questions

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

In the past two years, Jaguar Animal Health (JAGX) has reported FDA regulatory activity for the following drugs: Crofelemer, Crofelemer (SBS), Gelclair, Canalevia-CA1, NP-300 and NP300.

The most recent FDA-related event for Jaguar Animal Health occurred on June 25, 2025, involving Crofelemer. The update was categorized as "Provided Update," with the company reporting: "Jaguar Health, Inc. announced that the company plans to pursue approval from the European Medicines Agency's (EMA) Committee for Veterinary Medicinal Products (CVMP) for Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs."

Current therapies from Jaguar Animal Health in review with the FDA target conditions such as:

  • Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder - Crofelemer
  • Short Bowel Syndrome - Crofelemer (SBS)
  • For oral mucositis - Gelclair
  • For the treatment of chemotherapy-induced diarrhea (CID) in dogs. - Canalevia-CA1
  • Symptomatic Relief of Diarrhea from Cholera - NP-300
  • For Treatment of General Diarrhea in Dogs - NP300

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