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Drug

Naloxone

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as 1-N-Allyl-14-hydroxynordihydromorphinone, Bunavail, Buprenorphine-Naloxone, Evzio+15 more

1-N-Allyl-14-hydroxynordihydromorphinone, Bunavail, Buprenorphine-Naloxone, Evzio, Kloxxado, Narcan, Rextovy, Rezenopy, Suboxone, Talwin NX, Targiniq ER, Zimhi, Zubsolv, (-)-naloxone, Nalossone, Naloxona, Naloxone Hydrochloride, Naloxone Hydrochloride Dihydrate, Naloxonum.

5
Research papers
10
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

Regulatory2026-06-16Regulatory news · FDA Press Releases

Opioid Antagonism in Hypogonadotropic Hypogonadism

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Pilot Study of a Multi-System Analysis of Opioid Receptor Binding

Clinical trial2026-03-30Results expected Q3 2027 · ClinicalTrials.gov

Opioid use disorder: current trends and potential treatments.

Research2024-01-25Frontiers in public health

Nucleus accumbens D1/D2 circuits control opioid withdrawal symptoms in mice.

Research2023-09-15The Journal of clinical investigation

Approval: Nyxoid (EMA)

Regulatory2017-11-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Naloxone
Aliases & brands
1-N-Allyl-14-hydroxynordihydromorphinoneBunavailBuprenorphine-NaloxoneEvzioKloxxadoNarcanRextovyRezenopySuboxoneTalwin NXTarginiq ERZimhiZubsolv(-)-naloxoneNalossoneNaloxonaNaloxone HydrochlorideNaloxone Hydrochloride DihydrateNaloxonum
RxNorm CUI
7242
ChEMBL ID
CHEMBL80
ATC codes
A06AH04V03AB15
UNII
36B82AMQ7N
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-11-09
Latest approval
2017-11-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-11-09Approval
Approval: Nyxoid (EMA)
Indication: Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depressionShow full indication

Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and over. Nyxoid is not a substitute for emergency medical care.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

79 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
79
registered trials across all phases
LATEST COMPLETION 2025
10
Active studies
7
Recruiting
36
Late-stage (III+)
53
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 79
Early Phase 17Phase 117Phase 1 / 23Phase 216Phase 2 / 34Phase 36Phase 412Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20112023
Major research themes8
Drug Overdose2Analgesics, Opioid1Brain Death1Buprenorphine1Donor Selection1Heart Arrest1Lung Transplantation1Opiate Overdose1
Journals, researchers & institutions
Top journals
  • Anesthesiology1
  • COPD1
  • Frontiers in public health1
  • The Journal of clinical investigation1
  • Transplantation1
Leading researchers
  • Baird JC1
  • Blum K1
  • Dahan A1
  • Dang W1
  • Dhar R1
  • Florian J1
  • Fu X1
  • Fuehrlein BS1
Leading institutions
free-text, unnormalised
  • Behavioral Neuropharmacology and Neuroimaging Laboratory on Addictions1
  • Brigham and Women's Hospital1
  • Center for Drug Evaluation and Research1
  • Center for Sports1
  • College of Forensic Science1
  • Dartmouth Medical School1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 2 of the same disease areas as Naloxone in the shared literature.

2 shared diseases1 shared paper

Studied across the same disease area as Naloxone in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.