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Drug

Methadone

Approved · FDA
Emerging researchLate-stage developmentRising momentum
Also known as Diskets, Dolophine, dl-Methadone, (+-)-Methadone+7 more

Diskets, Dolophine, dl-Methadone, (+-)-Methadone, (±)-methadone, Metadona, Methadose, (+/-)-Methadone, 6-Dimethylamino-4,4-diphenyl-3-heptanone, Methadone Hydrochloride, Methadonum.

RxNorm6813ChEMBLCHEMBL651UNIIUC6VBE7V1Z
3
Research papers
31
Active clinical trials
8
Regulatory events
Latest activity
beta

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

Randomized Clinical Trial of Methadone and Ketamine for Pain Management During Deceased Donor Liver Transplant

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Oral Methadone In Cardiac Surgery

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Clinical trial2026-06-30Results posted · ClinicalTrials.gov

Bipartisan bill seeks to allow direct prescribing of methadone for opioid addiction

Industry2026-06-25STAT News

A Clinical Trial to Study the Effect of a Single Dose of Ulonivirine on the Pharmacokinetics of Methadone

Clinical trial2026-06-23Results expected Q1 2027 · ClinicalTrials.gov

Supplemental approval: METHADONE (ANDA204166)

Regulatory2026-06-18FDA

Label change: METHADONE (ANDA204166)

Regulatory2025-12-23FDA

Label change: METHADONE (ANDA204166)

Regulatory2025-03-27FDA

Supplemental approval: METHADONE (ANDA204166)

Regulatory2024-10-31FDA

Single-dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double-blind Clinical Trial.

Research2024-09-01Anesthesiology

Pharmacokinetic interaction between HCV protease inhibitor boceprevir and methadone or buprenorphine in subjects on stable maintenance therapy.

Research2015-02-11European journal of clinical pharmacology

Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: a randomized trial.

Research2012-08-22Drug and alcohol dependence

Profile

Identifiers & mechanism

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

Canonical name
Methadone
Aliases & brands
DisketsDolophinedl-Methadone(+-)-Methadone(±)-methadoneMetadonaMethadose(+/-)-Methadone6-Dimethylamino-4,4-diphenyl-3-heptanoneMethadone HydrochlorideMethadonum
RxNorm CUI
6813
ChEMBL ID
CHEMBL651
UNII
UC6VBE7V1Z
Regulatory jurisdictions
fda

Regulatory timeline

8 events

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
2020-03-16
Latest approval
2026-06-18
Authorities
FDA
Total events
8
fdaU.S. Food and Drug Administration· 8 events
2026-06-18Supplemental approval
Supplemental approval: METHADONE (ANDA204166)
Evidence ↗
2025-12-23Label change
Label change: METHADONE (ANDA204166)
Evidence ↗
2025-03-27Label change
Label change: METHADONE (ANDA204166)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

163 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
163
registered trials across all phases
LATEST COMPLETION 2025
31
Active studies
27
Recruiting
108
Late-stage (III+)
92
Completed
40
Discontinued
PHASE DISTRIBUTIONn = 163
Early Phase 14Phase 129Phase 1 / 25Phase 217Phase 2 / 33Phase 336Phase 452Phase N / A17

Late-stage studies

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

Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine

RecruitingPH IVMayo Clinicn=1402029

Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial

RecruitingPH IVDuke Universityn=4402029

Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial

RecruitingPH IVYale Universityn=6002028

Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study

RecruitingPH IVThe Cleveland Clinicn=1202028

A Prospective, Randomized Trial Utilizing Methadone in the Management of Post-Operative Pain in Total Knee Replacement

RecruitingPH IVAdventHealthn=1922028

Recent completions

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

Rapid IV Symptom-inhibited Fentanyl Induction (SIFI) to Facilitate Rotation Onto Oral Opioid Agonist Therapy (OAT)

CompletedPH IVPouya Azarn=482025

Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

CompletedPH IVMayo Clinicn=412025

Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients

CompletedPH IVUniversity of Southern Denmarkn=1292025

A Single-center, Randomized, Single-blind Pilot Study to Evaluate Intravenous Methadone Versus EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Adolescent and Juvenile Idiopathic Scoliosis Correction

CompletedPH IVDr. Casey Stondell, MDn=302024

Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)

CompletedPH IVDuke Universityn=9072024

Clinical Effectiveness and Safety of Intraoperative Methadone in Patients

CompletedN/AUniversity of Aarhusn=1142023

Research activity

3 papers

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

Publications over time
20132024
Major research themes8
Analgesics, Opioid1Intraoperative Care1Maintenance Chemotherapy1Methadone1Opiate Substitution Treatment1Pain Management1Postoperative Pain1Tonsillectomy1
Journals, researchers & institutions
Top journals
  • Anesthesiology1
  • Drug and alcohol dependence1
  • European journal of clinical pharmacology1
Leading researchers
  • Bruce RD2
  • Ang A1
  • Bilangi R1
  • Butterton JR1
  • Cohen A1
  • Doraimani G1
  • Einhorn LM1
  • Feng HP1
Leading institutions
free-text, unnormalised
  • Department of Clinical Pharmacology1
  • Duke Molecular Physiology Institute1
  • Duke University School of Medicine1
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.