Jupiter Neurosciences Receives FDA Clearance of IND Application to Initiate Phase 2a Clinical Trial of JOTROL™ in Parkinson’s Disease
Jupiter Neurosciences (NASDAQ:JUNS) announced that the FDA cleared its IND to initiate a Phase 2a clinical trial of JOTROL in Parkinson’s disease on November 5, 2025. The clearance enables enrollment for an exploratory Phase 2a study focused on safety and tolerability with secondary PK/PD and biomarker endpoints, and the company expects to begin enrollment in early 2026. Preclinical MPTP-model data showed improved motor endpoints; the company reports its micellar delivery achieves >9-fold higher bioavailability versus traditional resveratrol. Jupiter continues collaboration with Zina Biopharmaceuticals for protocol design and site selection.
Jupiter Neurosciences (NASDAQ:JUNS) ha annunciato che la FDA ha approvato il suo IND per iniziare uno studio clinico di Fase 2a di JOTROL nella malattia di Parkinson il 5 novembre 2025. L'autorizzazione consente l'arruolamento per uno studio esplorativo di Fase 2a focalizzato su sicurezza e tollerabilità con endpoint secondari PK/PD e biomarcatori, e l'azienda prevede di iniziare l'arruolamento nell'inizio del 2026. Dati preclinici nel modello MPTP hanno mostrato miglioramenti degli endpoint motori; l'azienda riporta che la sua somministrazione micellare raggiunge una biodisponibilità >9 volte superiore rispetto al resveratrolo tradizionale. Jupiter prosegue la collaborazione con Zina Biopharmaceuticals per la progettazione del protocollo e la selezione dei siti.
Jupiter Neurosciences (NASDAQ:JUNS) anunció que la FDA autorizó su IND para iniciar un ensayo clínico de Fase 2a de JOTROL en la enfermedad de Parkinson el 5 de noviembre de 2025. La autorización permite la inscripción para un estudio exploratorio de Fase 2a centrado en seguridad y tolerabilidad con endpoints secundarios PK/PD y biomarcadores, y la empresa espera comenzar la inscripción a principios de 2026. Datos preclínicos en el modelo MPTP mostraron mejoras en las métricas motoras; la empresa informa que su administración micelar logra una biodisponibilidad >9 veces mayor frente al resveratrol tradicional. Jupiter continúa la colaboración con Zina Biopharmaceuticals para el diseño del protocolo y la selección de sitios.
Jupiter Neurosciences (NASDAQ:JUNS)은 2025년 11월 5일 FDA가 JOTROL의 IND를 승인하여 파킨슨병에 대한 2a상 임상시험을 시작했다고 발표했습니다. 이 승인은 안전성 및 내약성에 초점을 맞춘 탐색적 2a상 연구의 선수 등록을 가능하게 하며 PK/PD 및 바이오마커 엔드포인트를 보조로 하며 회사는 2026년 초에 등록을 시작할 것으로 기대합니다. 전임상 MPTP 모델 데이터는 운동 엔드포인트의 개선을 보여주었고, 회사는 미셀럴 전달이 전통적 레스베라트롤에 비해 9배 이상 높은 생체이용률을 달성한다고 보고합니다. Jupiter는 프로토콜 설계 및 연구기관 선택을 위해 Zina Biopharmaceuticals와의 협업을 계속합니다.
Jupiter Neurosciences (NASDAQ:JUNS) a annoncé que la FDA a autorisé son IND pour démarrer un essai clinique de phase 2a de JOTROL dans la maladie de Parkinson le 5 novembre 2025. Cette autorisation permet l’inscription à une étude exploratoire de phase 2a axée sur la sécurité et la tolérance avec des critères secondaires PK/PD et biomarqueurs, et la société prévoit de commencer l’inscription au début de 2026. Des données précliniques du modèle MPTP ont montré une amélioration des critères moteurs; la société indique que sa délivrance micellaire atteint une biodisponibilité >9 fois supérieure à celle du resvératrol traditionnel. Jupiter poursuit sa collaboration avec Zina Biopharmaceuticals pour la conception du protocole et la sélection des sites.
Jupiter Neurosciences (NASDAQ:JUNS) gab bekannt, dass die FDA seinen IND genehmigt hat, um eine Phase-2a-Studie von JOTROL bei Parkinson zu initiieren, am 5. November 2025. Die Genehmigung ermöglicht die Rekrutierung für eine explorative Phase-2a-Studie, die sich auf Sicherheit und Verträglichkeit konzentriert, mit sekundären PK/PD- und Biomarker-Endpunkten; das Unternehmen geht davon aus, die Rekrutierung Anfang 2026 zu beginnen. Präklinische MPTP-Modell-Daten zeigten verbesserte motorische Endpunkte; das Unternehmen berichtet, dass seine mikellare Abgabe eine >9-fach höhere Bioverfügbarkeit gegenüber traditionelle Resveratrol erreicht. Jupiter setzt die Zusammenarbeit mit Zina Biopharmaceuticals fort, um Versuchsprotokoll und Site-Auswahl zu gestalten.
Jupiter Neurosciences (NASDAQ:JUNS) أعلنت أن إدارة الغذاء والدواء الأمريكية FDA صادقت على IND الخاصة بها لبدء تجربة سريرية من المرحلة 2a لـ JOTROL في مرض باركنسون في 5 نوفمبر 2025. تتيح المصادقة تسجيل المشاركين في دراسة المرحلة 2a استكشافية تركز على السلامة والتحمّل مع نقاط نهاية PK/PD وبايوماركر، وتتوقع الشركة البدء في التسجيل في بداية 2026. أظهرت بيانات ما قبل السريرية في نموذج MPTP تحسنًا في المعايير الحركية؛ وتذكر الشركة أن التوصيل الميَيسِلي يحقق >9 أضعاف في التوافر الحيوي مقارنةً بالريسفيراترول التقليدي. وتواصل Jupiter التعاون مع Zina Biopharmaceuticals لتصميم البروتوكول واختيار المواقع.
- FDA cleared IND for Phase 2a Parkinson’s trial (Nov 5, 2025)
- Trial enrollment expected in early 2026
- Preclinical MPTP model: improved rotarod and grip strength
- Micellar delivery: >9-fold higher bioavailability vs resveratrol
- Ongoing collaboration with Zina Biopharmaceuticals for protocol/site support
- Phase 2a is exploratory safety/tolerability; no clinical efficacy yet
- Disease‑modifying claims remain preclinical and unproven in humans
- Timing and enrollment depend on future operational milestones
Insights
FDA cleared an IND for JOTROL, allowing a Phase 2a Parkinson's trial and planned enrollment in
Jupiter Neurosciences now holds FDA clearance to start a Phase 2a study testing JOTROL in Parkinson’s disease focused on safety and tolerability with secondary PK/PD and exploratory biomarker endpoints. The program advances after Phase I safety and preclinical efficacy signals described in the release, and the company will continue protocol collaboration with Zina Biopharmaceuticals, LLC.
Risks and dependencies center on trial execution and the readout scope: the announced study is exploratory and designed primarily for safety and PK/PD rather than efficacy, and successful enrollment and data quality will determine near-term value. The firm cites preclinical MPTP-model motor improvements and a proprietary micellar delivery system claiming >nine-fold bioavailability versus traditional resveratrol, which support the rationale but remain preclinical or formulation claims until clinical PD endpoints are measured.
Watch for concrete, monitorable milestones: trial initiation and first patient dosing in
Jupiter, Florida, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, today 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.
The FDA’s clearance marks a significant regulatory milestone for Jupiter, enabling the Company to begin enrollment in its exploratory Phase 2a trial designed to evaluate the safety and tolerability of JOTROL in patients with Parkinson’s, with secondary and exploratory endpoints to assess pharmacokinetics/pharmacodynamics (PK/PD) of the drug.
“This IND clearance from the FDA is an important step forward for Jupiter and the Parkinson’s community,” said Christer Rosén, Chairman and CEO of Jupiter Neurosciences. “JOTROL’s unique formulation has demonstrated strong safety and bioavailability data in Phase I and preclinical evidence suggests neuroprotective benefits that may translate into disease-modifying potential in Parkinson’s. We are proud to advance this innovative program and are now one step closer to initiating patient dosing.”
As Jupiter advances toward trial initiation, the Company will continue its collaboration with Zina Biopharmaceuticals, LLC, which has supported trial protocol design, including pharmacokinetic and biomarker planning, and is assisting with site selection. With IND clearance in place, Jupiter expects to begin trial enrollment in early 2026.
Preclinical studies using the MPTP model of Parkinson’s disease demonstrated that JOTROL improved key motor function endpoints such as rotarod performance and grip strength, consistent with neuroprotective effects. The Company’s proprietary micellar delivery system enables JOTROL to achieve more than nine-fold higher bioavailability than traditional resveratrol, while avoiding the gastrointestinal side effects that have historically limited the compound’s therapeutic utility.
Parkinson’s disease affects over 10 million people worldwide, with no disease-modifying treatments currently available. The global Parkinson’s therapeutics market is projected to exceed
About Jupiter Neurosciences, Inc.
Jupiter Neurosciences is a clinical-stage pharmaceutical company pursuing a dual-path strategy to address neuroinflammation and promote healthy aging. The Company is advancing a therapeutic pipeline targeting central nervous system (CNS) disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia product line. Both efforts are powered by JOTROL™, Jupiter’s proprietary, enhanced resveratrol formulation that has demonstrated significantly improved bioavailability. Nugevia brings clinical-grade science to the supplement space, supporting mental clarity, skin health, and mitochondrial function. The Company’s prescription pipeline is focused broadly on CNS disorders, presently with a Phase IIa in Parkinson’s disease, including indications such as Alzheimer’s Disease, Mucopolysaccharidoses Type I, Friedreich’s Ataxia, and MELAS. More information may be found on the Company’s website www.jupiterneurosciences.com.
About JOTROL
Resveratrol is one of the world’s most extensively researched molecules. Thorough evaluation has shown that for the compound to be effective, it requires a high C-Max (~300 ng/ml of resveratrol in plasma), achievable only with doses exceeding 3 grams using earlier resveratrol products. Poor bioavailability has been a well-documented issue with resveratrol. Doses over 2 grams have been associated with severe gastrointestinal (GI) side effects, which have prevented the compound from receiving regulatory approval for any indication.
Jupiter Neurosciences (JUNS) conducted a Phase I study demonstrating that JOTROL™ achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner et al., MCI/Early Alzheimer’s Disease trial, and Yui et al., Friedreich’s Ataxia trial). The results of this Phase I study, which will be cross-referenced in all upcoming JOTROL™ trials, were published in the Journal of Alzheimer’s Disease and AAPS Open in February 2022. JUNS is now advancing JOTROL™ toward a Phase IIa trial in Parkinson’s Disease.
In addition to its therapeutic applications, JOTROL™ serves as the foundation for Jupiter’s Nugevia consumer supplement line. By leveraging the same clinically validated delivery technology, Nugevia introduces pharmaceutical-grade bioavailability into the wellness space, offering targeted support for cognitive health, skin vitality, and cellular energy.
FORWARD-LOOKING STATEMENTS
Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations, including the Company’s ability to generate revenues from the sale of JOTROL products to consumers through the DTC model. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.
Contact:
IR@jupiterneurosciences.com
JUNS@redchip.com
FAQ
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