Narcan

(Naloxone Nasal Spray)

Small molecule

SScienture

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q1 2030

Phase 3Active, not recruiting

Opioid Use Disorder

NCT06089707

Clinical

Trials by Indication[1]

Opioid Use Disorder1 trial

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

Active, not recruiting·JJohns Hopkins University·Phase 3·NCT06089707·3 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 1, 1982

NARCAN

NDA NDA016636

Apr 3, 2014

EVZIO

NDA NDA205787

Oct 19, 2016

EVZIO (AUTOINJECTOR)

NDA NDA209862

Jan 24, 2017

NARCAN

NDA NDA208411

Oct 15, 2021

ZIMHI

NDA NDA212854

Feb 28, 2022

NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

NDA NDA215457

Mar 7, 2023

REXTOVY

NDA NDA208969

Jul 28, 2023

RIVIVE

NDA NDA217722

Apr 19, 2024

REZENOPY

NDA NDA215487

Aug 25, 2025

KLOXXADO

NDA NDA212045

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Naloxone Nasal Spray. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naloxone Nasal Spray compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA212045). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Scienture company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: SScienture