NALOXONE (naloxone hydrochloride) · Hikma
Naloxone Hydrochloride Injection, USP is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1985-10-02
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NALOXONE Approval History
What NALOXONE Treats
1 indicationsNALOXONE is approved for 1 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
NALOXONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NALOXONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
33 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04975334 results posted | 313510 | Ph 1 | completed | Opioid Antagonism in Hypogonadotropic Hypogonadism |
| NCT03897998 | HP-00085382 | Ph 2 | completed | Neural Correlates of Hypoalgesia Driven by Observation |
| NCT05528848 | 851051 | Ph 1 | active not recruiting | Multi-System Analysis of Opioid Receptor Binding |
| NCT07459166 | CS-1103-03 5UG3DA059286 | Ph 2 | recruiting | A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade |
| NCT04851301 | HP-00095888 | Ph 1, Ph 2 | active not recruiting | Neural Mechanisms of Immersive Virtual Reality in Chronic Pain |
| NCT04975347 | 313512 | Ph 1 | completed | Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank |
| NCT02332447 ENALEPSY | 2014-853 2014-003003-30 | Ph 3 | completed | Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy |
| NCT03608163 results posted | 2018-9208 R01DK079974 | Ph 4 | terminated | Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF) |
| NCT04828005 results posted | OPNT003-PD-001 | Ph 1 | completed | Pharmacodynamic Evaluation of Intranasal Nalmefene |
| NCT03751111 results posted | 2018/NAL/CSU/PRU | Ph 1, Ph 2 | completed | Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone |
| NCT04473950 results posted | Z-1902 R21DA047520 | Ph 1 | terminated | The Effect of Chronic Pain on Delay Discounting in Methadone Patients |
| NCT05114460 results posted | 8061 | Ph 2 | terminated | Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal |
| NCT05338632 ROAR | P21.112 | Ph 1 | terminated | Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists |
| NCT01952782 | 2013P001543 | Ph 1 | completed | Neuropeptides in Human Reproduction |
| NCT03176316 FusionIleus results posted | 209439 | Ph 4 | terminated | The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus |
| NCT02684669 TCI-NX-BI | H-15018869-BI | Ph 2 | completed | Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia During a Burn Injury |
| NCT02976337 TME | H-15018869-TME | Ph 2 | completed | Effect of High-dose Naloxone Following Third Molar Extraction |
| NCT02805972 BEE results posted | 16-19392 | Ph 2 | completed | Biology and Experience of Eating in Women With Obesity |
| NCT03851731 | Naltrexone-Ph1a-001 | Ph 1 | completed | Evaluation of Intranasal Naltrexone and Naloxone |
| NCT02581111 NO-HOLDS results posted | ODRC-001 | Ph 2, Ph 3 | completed | Naloxone for Optimizing Hypoxemia Of Lung Donors |
| NCT01109511 | targiniqoxycodulleval | Ph 4 | completed | A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy |
| NCT03386591 | Naloxone P1a-003 | Ph 1 | completed | Comparison of Naloxone Pharmacokinetics |
| NCT02885948 NAPRESSIM | UCDCRC/15/006 | Ph 4 | completed | The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine. |
| NCT01071057 | H09-03001 | Ph 2, Ph 3 | completed | Naloxone for the Treatment of Opioid-Induced Pruritus |
| NCT02572089 | Naloxone-Phase1a-002 | Ph 1 | completed | Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers |
| NCT02321397 | OXN3508 2013-004888-31 | Ph 2, Ph 3 | completed | To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain |
| NCT02137213 | 083/2013 | Ph 2 | completed | Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation |
| NCT02045693 | AI443-108 | Ph 1 | completed | Drug Interaction & Methadone & Buprenorphine |
| NCT01596764 | LOP-MNTX-2011 | Ph 1 | completed | Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time. |
| NCT01191645 | JS002 | Ph 4 | completed | Opioid Effects on Swallowing and Esophageal Sphincter Pressure |
| NCT00678145 results posted | 2012-665 R01DK079974 | Ph 2 | terminated | Mechanisms of Hypoglycemia Associated Autonomic Failure |
| NCT05142267 | 210399 R01DA050334 | Ph 4 | completed | Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms |
| NCT07806565 naloxone-IHCA | 2026-525323-24-00 2026-525323-24-00 | Ph 2, Ph 3 | not yet recruiting | Naloxone for In-Hospital Cardiac Arrest |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NALOXONE FDA Label Details
Indications & Usage
Naloxone Hydrochloride Injection, USP is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone Hydrochloride Injection, USP is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone Hydrochloride Injection, USP may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACO...
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KLOXXADO
Full clinical data, patents, trials, and competitive landscape for naloxone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment