Scienture (SCNX) has upcoming FDA regulatory milestones for Arbli. The table below outlines estimated target dates and event types for these pending regulatory actions.
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, Arbli, 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 Timeline and 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 11, 2026
- Indication:
- opioid overdose emergency treatment
Announcement
SCIENTURE HOLDINGS, announced that it has formalized multiple commercial Group Purchasing Organization (GPO) agreements for REZENOPYTM (naloxone HCl) Nasal Spray 10 mg, providing access to more than 5000 healthcare institutions, including hospitals, clinics and nursing homes, representing potential penetration into roughly 60% of the U.S. institutional market while also establishing a broad footprint across first responders, EMS providers and rehabilitation centers.
AI Summary
Scienture Holdings announced multiple commercial Group Purchasing Organization (GPO) agreements for REZENOPY™ (naloxone HCl) Nasal Spray 10 mg, giving access to over 5,000 healthcare institutions — including hospitals, clinics, and nursing homes — and representing potential penetration into roughly 60% of the U.S. institutional market. These GPO contracts are designed to speed purchasing and distribution across large health systems.
The agreements also establish a broad footprint with first responders, EMS providers, and rehabilitation centers, improving access where opioid overdoses are likely to occur. REZENOPY™ is a 10 mg naloxone nasal spray indicated for emergency treatment of known or suspected opioid overdose and is supplied as single‑use intranasal devices.
The U.S. naloxone market totals about $141 million with roughly 9.4 million prescription units annually, highlighting a significant commercial opportunity for REZENOPY™ if institutional adoption follows these GPO placements.
Read Announcement- Drug:
- REZENOPY
- Announced Date:
- January 14, 2026
- Indication:
- opioid overdose emergency treatment
Announcement
SCIENTURE HOLDINGS, announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent covering REZENOPY™ (naloxone HCl) Nasal Spray 10 mg, effective January 6, 2026, with an expiry date of February 5, 2041.
AI Summary
Scienture Holdings announced the U.S. Patent and Trademark Office issued U.S. Patent No. 12,514,854 B2, an Orange Book‑listable patent covering REZENOPY™ (naloxone HCl) Nasal Spray 10 mg, effective January 6, 2026, with expiry on February 5, 2041. The patent was issued to Summit Biosciences Inc., a subsidiary of Kindeva, under the collaboration that gives Scienture exclusive U.S. commercialization rights. Summit will manufacture and supply REZENOPY™, and, pending certain commercial obligations, Scienture will hold the NDA and lead sales, marketing, and distribution in the U.S.
The Orange Book eligibility may add intellectual property protection to support long‑term commercialization. REZENOPY™ is a differentiated, high‑dose naloxone nasal spray aimed at countering potent opioids. With U.S. naloxone sales near $154 million and about 9.3 million units annually, Scienture says the new patent strengthens its position to pursue the market opportunity and lifecycle management for the product.
Read Announcement- Drug:
- REZENOPY
- Announced Date:
- December 22, 2025
- Indication:
- opioid overdose emergency treatment
Announcement
SCIENTURE HOLDINGS provided an update on the commercial launch of REZENOPY®.
AI Summary
Scienture Holdings provided an update on the commercial launch of REZENOPY®, a 10 mg naloxone nasal spray intended for emergency treatment of opioid overdose. As the highest-strength naloxone option, REZENOPY is aimed at situations where patients often require multiple lower-strength doses. IQVIA data (MAT Sept 2025) estimates the U.S. naloxone market at about $154 million in annual sales and 9.3 million units per year.
Scienture said manufacturing is on track and the product is expected to be ready in Q1 2026. The company plans to load REZENOPY into the wholesale channel during Q1 2026, with commercial availability beginning in early Q2 2026. REZENOPY is supplied as a carton containing two blister packages, each with a single intranasal spray device for adults and pediatric patients.
Key usage and safety points: administer one spray into one nostril and seek emergency medical care immediately. If there's no response in 2–3 minutes or the patient relapses, give another spray into the other nostril using a new device; do not administer more than two sprays per day. Scienture says the 10 mg dose may help address overdoses involving potent opioids.
Read Announcement- 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.
Read Announcement
Arbli FDA Regulatory Timeline and Events
Arbli is a drug developed by Scienture for the following indication: for 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:
- Arbli
- Announced Date:
- February 3, 2026
- Target Action Date:
- Q2 2026
- Estimated Target Date Range:
- April 1, 2026 - June 30, 2026
- Indication:
- for hypertension
Announcement
SCIENTURE HOLDINGS, INC provided a commercial update on ARBLI™ (losartan potassium) oral suspension, the first and only FDA-approved ready-to-use oral liquid formulation of losartan, alongside key market access achievements, financial strengthening initiatives, and near-term outlook—including reaffirming its plan to commercially launch REZENOPY™, a life-saving opioid overdose emergency treatment, in the second quarter of 2026.
AI Summary
Scienture Holdings provided a commercial update on ARBLI™, highlighting recent market access wins that expand patient reach across retail, institutional, and managed care channels. The company secured GPO agreements, broadened formulary inclusion, and partnered with BlinkRx to increase availability. Management noted these steps materially expand ARBLI’s commercial opportunity within the roughly $241 million U.S. losartan market (about 72 million annual prescriptions) and contribute to a combined U.S. losartan and naloxone market of close to $385 million.
ARBLI is the first and only FDA‑approved ready‑to‑use oral liquid formulation of losartan, supplied as a 165 mL peppermint suspension that does not require refrigeration and has a 24‑month shelf life. For Q1 2026, Scienture expects continued sequential prescription growth, improved commercial efficiency as early investments drive recurring demand, and further payer and pharmacy engagement to broaden access across commercial and government sectors.
Scienture also reported significant balance sheet improvement last quarter and reaffirmed its plan to commercially launch REZENOPY™ (naloxone HCl nasal spray 10 mg) for emergency opioid overdose treatment in the second quarter of 2026.
Read Announcement- Drug:
- Arbli
- Announced Date:
- October 23, 2025
- Indication:
- for hypertension
Announcement
SCIENTURE HOLDINGS, announced the start of commercial sales and fulfillment of the first customer orders for Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL, marking an important milestone in the Company's growth as it begins to bring this differentiated product to market.
AI Summary
Scienture Holdings announced it has begun commercial sales of Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL, and delivered its first customer orders. This launch marks a key milestone as the company brings this new product to patients.
Arbli™ is FDA-approved as the first ready-to-use liquid form of losartan potassium, giving a safe and convenient alternative to pills in a market worth about $256 million each year with over 71 million prescriptions.
Scienture launched a multi-channel campaign targeting health care professionals and finalized agreements with pharmacy benefit managers and group purchasing organizations. These agreements expand Arbli’s coverage in over 2,500 hospitals, clinics, nursing homes, and pharmacies nationwide.
The company said the start of sales shows its shift from development to execution. Expecting demand to grow, Scienture will expand education and awareness efforts based on early positive feedback from health care institutions.
Read Announcement- Drug:
- Arbli
- Announced Date:
- October 16, 2025
- Indication:
- for hypertension
Announcement
SCIENTURE HOLDINGS announced that Arbli™ (losartan potassium) Oral Suspension, 10mg/mL, is commercially available through full-line wholesalers nationwide.
AI Summary
Scienture Holdings has made Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL, commercially available through full-line wholesalers nationwide. This liquid formulation is the first and only FDA-approved ready-to-use losartan suspension.
With the U.S. losartan market at $256 million and 71 million annual prescriptions, Arbli™ meets a clear need for patients who cannot swallow tablets, such as children over six and elderly adults with dysphagia.
Previously, these patients relied on inconsistent compounded versions. Arbli™ eliminates compounding risks and offers a consistent peppermint-flavored suspension that does not require refrigeration and has a 24-month shelf life at room temperature.
This launch marks a strategic expansion into the broader hypertension market and supports better treatment adherence by providing an easy-to-use, ready-made option accessible through existing pharmaceutical supply chains.
By offering a dependable, liquid ARB option, Scienture aims to improve patient safety and capture a share of this high-volume market.
Read Announcement
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.
Read Announcement
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