FDA Events for Jupiter Neurosciences (JUNS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Jupiter Neurosciences (JUNS).
Over the past two years, Jupiter Neurosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
JOTROL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
JOTROL - FDA Regulatory Timeline and Events
JOTROL is a drug developed by Jupiter Neurosciences for the following indication: For Parkinson's disease.
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.
- Drug:
- JOTROL
- Announced Date:
- February 3, 2025
- Indication:
- For Parkinson's disease.
Announcement
Jupiter Neurosciences, Inc. announced it has entered into an agreement with Catalent Pharma Solutions, LLC ("Catalent") for the production of JOTROL™ softgel capsules to support Jupiter's upcoming Phase 2a clinical trial in Parkinson's disease.
AI Summary
Jupiter Neurosciences, Inc. has partnered with Catalent Pharma Solutions for the production of its JOTROL™ softgel capsules, which are being prepared to support an upcoming Phase 2a clinical trial in Parkinson’s disease. Under the agreement, Catalent will manufacture clinical batches—both active and placebo—using an optimized softgel formulation designed to enhance the bioavailability of resveratrol while reducing gastrointestinal side effects. This manufacturing process will adhere to current Good Manufacturing Practices (CGMP) standards, ensuring it meets the regulatory requirements for the clinical trial. The collaboration with a leading contract development and manufacturing organization like Catalent is a crucial step for Jupiter as it works to advance JOTROL into the clinical stage, offering hope for improved treatment options in Parkinson’s disease therapy.
Read Announcement
Jupiter Neurosciences FDA Events - Frequently Asked Questions
As of now, Jupiter Neurosciences (JUNS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Jupiter Neurosciences (JUNS) has reported FDA regulatory activity for JOTROL.
The most recent FDA-related event for Jupiter Neurosciences occurred on February 3, 2025, involving JOTROL. The update was categorized as "Provided Update," with the company reporting: "Jupiter Neurosciences, Inc. announced it has entered into an agreement with Catalent Pharma Solutions, LLC ("Catalent") for the production of JOTROL™ softgel capsules to support Jupiter's upcoming Phase 2a clinical trial in Parkinson's disease."
Currently, Jupiter Neurosciences has one therapy (JOTROL) targeting the following condition: For Parkinson's disease..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:JUNS) was last updated on 7/9/2025 by MarketBeat.com Staff
