Methadone Hydrochloride

Phase 3Small molecule

NNational Institute of Allergy and Infectious Diseases (NIAID)

Methadone Hydrochloride is one of 47 small molecule programs targeting Opioid Use Disorder (OUD). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Opioid Use Disorder (OUD)Recruiting

Post Operative PainRecruiting

Opioid Use Disorder (OUD)Phase 1

Recruiting

Post Operative PainPhase 3

Recruiting

Competition

Competitive Landscape

61 competitors in Post Operative Pain

#DrugCompanyPhaseTrials

Marcaine

IInnocoll

Approved

25 2

Advil

KKenvue Brands

Approved

16 3

Duragesic

CCephalon

Approved

11 4

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

10 5

Oxycontin

PProtega

Approved

9 6

Ketalar

AAultman Health Foundation

Approved

9 7

Epsom Salt

FFresenius Kabi USA, LLC

Approved

7 8

Tylenol

KKenvue Brands

Approved

6 9

Achromycin V

WWyeth-Lederle Vaccines

Approved

1 10

EXPAREL

Pacira Pharmaceuticals, Inc

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Methadone

NCT07226076

Q3 2027

Phase 1Recruiting

Study completion

NCT06877858

Post-ApprovalRecruiting

Cleft Palate

NCT06962306

Clinical

Trials by Indication[1]

Methadone6 trials

Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Terminated·MM.D. Anderson Cancer Center·N/A·NCT00726830·1 enrolled

A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001008·18 enrolled

Epidural Methadone in Healthy Volunteers

Completed·Ssimon.haroutounian·Phase 1·NCT03525509·13 enrolled

Show 3 more trials

Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000800·15 enrolled

Methadone in TKA for Post-op Pain and Opioid Reduction

Recruiting·MMedical University of South Carolina·Phase 3·NCT07226076·162 enrolled

A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000788·24 enrolled

Spinal Fusion2 trials

Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

Terminated·MMontefiore Medical Center·Phase 4·NCT02989597·10 enrolled

Methadone vs Magnesium in Spinal Fusion

Completed·NNationwide Children's Hospital·Phase 2·NCT01795495·63 enrolled

Head and Neck Cancer1 trial

Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

Completed·RRoswell Park Cancer Institute·Phase 1·NCT02531906·60 enrolled

Intraoperative1 trial

Intraoperative Methadone in Children Undergoing Surgery

Terminated·UUniversity of Aarhus·Phase 3·NCT04680286·60 enrolled

Effectiveness1 trial

Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions

Unknown status·TThe Methodist Hospital Research Institute·Phase 1·NCT04112550·150 enrolled

6 more indications

Interaction1 trial

Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000906·12 enrolled

Post Operative Pain1 trial

Intraoperative Methadone for the Prevention of Postoperative Pain

Recruiting·—·Phase 3·NCT05831345·80 enrolled

Cancer Pain1 trial

Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain

Terminated·NNCIC Clinical Trials Group·Phase 1·NCT00930332·8 enrolled

Hip Fracture1 trial

Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients

Completed·UUniversity of Southern Denmark·Phase 4·NCT06086171·129 enrolled

Cleft Palate1 trial

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Recruiting·—·Phase 4·NCT06962306·60 enrolled

Unspecified1 trial

MethaLoad Dose-Finding Study

Recruiting·UUniversity of Pennsylvania·Phase 1·NCT06877858·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Methadone Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Methadone Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Methadone Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Institute of Allergy and Infectious Diseases (NIAID) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNational Institute of Allergy and Infectious Diseases (NIAID)

Methadone Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Trials by Indication[1]

Methadone6 trials

Spinal Fusion2 trials

Head and Neck Cancer1 trial

Intraoperative1 trial

Effectiveness1 trial

Interaction1 trial

Post Operative Pain1 trial

Cancer Pain1 trial

Hip Fracture1 trial

Cleft Palate1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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