This section highlights FDA-related milestones and regulatory updates for drugs developed by Scienture (SCNX).
Over the past two years, Scienture has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
REZENOPY and SCN-102. 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.
REZENOPY FDA Regulatory Events
REZENOPY is a drug developed by Scienture for the following indication: opioid overdose emergency treatment.
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:
- REZENOPY
- Announced Date:
- March 6, 2025
- Indication:
- opioid overdose emergency treatment
Announcement
SCIENTURE HOLDINGS, INC. is pleased to announce that its wholly owned subsidiary, Scienture, LLC ("Scienture"), has entered into a definitive agreement with SUMMIT BIOSCIENCES INC. (a wholly owned subsidiary of Kindeva Drug Delivery L.P. ("Kindeva")), for the exclusive U.S. rights to commercially launch REZENOPY® (naloxone HCl) Nasal Spray 10mg, an opioid antagonist that was approved by the FDA on April 19, 2024.
AI Summary
SCIENTURE HOLDINGS, INC. announced that its subsidiary, Scienture, LLC, has signed a definitive agreement with SUMMIT BIOSCIENCES INC.—a subsidiary of Kindeva Drug Delivery L.P.—to secure the exclusive U.S. rights to launch REZENOPY® (naloxone HCl) Nasal Spray 10mg. This opioid antagonist, approved by the FDA on April 19, 2024, is the most potent version of naloxone available, designed to counteract severe opioid overdoses.
Under the agreement, Kindeva will manufacture and commercially supply the nasal spray, while Scienture will hold the new drug application and manage its sales, marketing, and distribution across the U.S. The collaboration aims to strengthen public health initiatives by providing a high-dose, user-friendly emergency treatment option for opioid overdoses, thereby expanding access to life-saving interventions.
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SCN-102 FDA Regulatory Events
SCN-102 is a drug developed by Scienture for the following indication: For the treatment of hypertension.
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:
- SCN-102
- Announced Date:
- March 18, 2025
- Indication:
- For the treatment of hypertension
Announcement
SCIENTURE HOLDINGS, announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL.
AI Summary
Scienture Holdings recently announced that the U.S. Food and Drug Administration has approved SCN-102, a significant development from its subsidiary Scienture, LLC. The product, branded as ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL, is designed for treating hypertension in patients over the age of six, reducing stroke risk in those with left ventricular hypertrophy, and managing diabetic nephropathy in specific type 2 diabetes patients.
ArbliTM is notable for being the very first FDA-approved ready-to-use liquid form of losartan in the U.S., offering a safe alternative to compounded tablet formulations. This innovative liquid dosage ensures reliable and convenient dosing, along with a long shelf life at room temperature. The company plans to commercially launch ArbliTM in the U.S. in the third quarter of 2025, marking a major step in delivering tailored treatment options to patients.
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