Jupiter Neurosciences (JUNS) FDA Approvals $0.32 -0.01 (-3.70%) Closing price 03:59 PM EasternExtended Trading$0.32 +0.01 (+1.56%) As of 07:38 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Jupiter Neurosciences' Drug in the FDA Approval ProcessThis 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 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. FDA Clearance - November 5,2025Fda Clearance INDDrug: JOTROLAnnounced Date: November 5, 2025Indication: For Parkinson's disease.AnnouncementJupiter Neurosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of JOTROL™ in patients with Parkinson's disease.AI SummaryJupiter Neurosciences, Inc. announced that the FDA has cleared its IND application for a Phase 2a clinical trial of JOTROL™ in Parkinson’s disease patients. This regulatory milestone lets Jupiter start enrolling participants in early 2026. The study will assess safety and tolerability as primary endpoints and will include pharmacokinetic and pharmacodynamic measures as secondary and exploratory endpoints. Jupiter is working with Zina Biopharmaceuticals on trial protocol design and site selection. JOTROL™ is a patented resveratrol-based therapy that targets neuroinflammation and mitochondrial dysfunction. Preclinical studies showed improved motor functions in Parkinson’s models, and earlier data demonstrated strong safety and over ninefold higher bioavailability compared to traditional resveratrol. Jupiter hopes this trial will reveal disease-modifying potential and advance treatment options for over 10 million people living with Parkinson’s worldwide.Read AnnouncementProvided Update - February 3,2025Provided Update Drug: JOTROLAnnounced Date: February 3, 2025Indication: For Parkinson's disease.AnnouncementJupiter 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 SummaryJupiter 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 Has Jupiter Neurosciences received FDA approval? As of now, Jupiter Neurosciences (JUNS) has not received any FDA approvals for its therapy in the last two years. What drugs has Jupiter Neurosciences submitted to the FDA? In the past two years, Jupiter Neurosciences (JUNS) has reported FDA regulatory activity for JOTROL. What is the most recent FDA event for Jupiter Neurosciences? The most recent FDA-related event for Jupiter Neurosciences occurred on November 5, 2025, involving JOTROL. The update was categorized as "FDA Clearance," with the company reporting: "Jupiter Neurosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of JOTROL™ in patients with Parkinson's disease." What conditions do Jupiter Neurosciences' current drugs treat? Currently, Jupiter Neurosciences has one therapy (JOTROL) targeting the following condition: For Parkinson's disease.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Alterity Therapeutics FDA EventsBlack Diamond Therapeutics FDA EventsJaguar Animal Health FDA EventsLipocine FDA EventsLantern Pharma FDA EventsZenas BioPharma FDA EventsMerck & Co., Inc. FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex Therapeutics FDA Events 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 Related Companies Incannex Healthcare FDA Events Plus Therapeutics FDA Events SCYNEXIS FDA Events Tempest Therapeutics FDA Events Marker Therapeutics FDA Events VYNE Therapeutics FDA Events Lipocine FDA Events Traws Pharma FDA Events NLS Pharmaceutics FDA Events Scienture FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:JUNS last updated on 11/6/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersSpaceX eyes a 1.75 trillion valuation - here's what to knowElon Musk's team has quietly filed confidential paperwork with the SEC for what Bloomberg estimates could be a...Brownstone Research | SponsoredIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of ...American Alternative | Sponsored$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s kno...Paradigm Press | SponsoredTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredMy feud with Zohran MamdaniEmmy-winning analyst releases his next big story Whitney Tilson shocked the nation on 60 Minutes when he ac...Stansberry Research | SponsoredIran War Shock: What I Was Told In That Private MeetingYou’re Being LIED To About The Iran War Forget EVERYTHING you’ve heard about the Iran war. Especially th...Banyan Hill Publishing | SponsoredWhy this tiny stock may move before the SpaceX IPO dropsThe projected SpaceX and xAI S-1 filing hits the SEC on June 1st - and analyst Dylan Jovine says $1.75 trillio...Behind the Markets | SponsoredSpaceX IPO hides a much bigger storyThe SpaceX IPO could be the biggest in history at $1.75 trillion - but the real story isn't the IPO itself. ...Weiss Ratings | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Jupiter Neurosciences, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Jupiter Neurosciences With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Clearance - November 5,2025Fda Clearance INDDrug: JOTROLAnnounced Date: November 5, 2025Indication: For Parkinson's disease.AnnouncementJupiter Neurosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of JOTROL™ in patients with Parkinson's disease.AI SummaryJupiter Neurosciences, Inc. announced that the FDA has cleared its IND application for a Phase 2a clinical trial of JOTROL™ in Parkinson’s disease patients. This regulatory milestone lets Jupiter start enrolling participants in early 2026. The study will assess safety and tolerability as primary endpoints and will include pharmacokinetic and pharmacodynamic measures as secondary and exploratory endpoints. Jupiter is working with Zina Biopharmaceuticals on trial protocol design and site selection. JOTROL™ is a patented resveratrol-based therapy that targets neuroinflammation and mitochondrial dysfunction. Preclinical studies showed improved motor functions in Parkinson’s models, and earlier data demonstrated strong safety and over ninefold higher bioavailability compared to traditional resveratrol. Jupiter hopes this trial will reveal disease-modifying potential and advance treatment options for over 10 million people living with Parkinson’s worldwide.Read Announcement
Provided Update - February 3,2025Provided Update Drug: JOTROLAnnounced Date: February 3, 2025Indication: For Parkinson's disease.AnnouncementJupiter 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 SummaryJupiter 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
