Dolophine
(Methadone)ApprovedSmall molecule
Methadone is used to treat severe pain and to help people stop using heroin or other opioids by reducing cravings and withdrawal symptoms.[2] Dolophine is currently approved and in use across 33 indications[4].[1]
Dolophine is one of 679 small molecule programs targeting Premature Birth. It is currently in Approved.
33
Indications
151
Total Trials
24
Active Trials
678
Competitors
6
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 31 indications
Competition
Competitive Landscape
540 competitors in Chronic Kidney Disease
#DrugCompanyPhaseTrials
1Dolophine
HHikma Pharmaceuticals LLC
Approved
Epogen
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Preclinical
Uloric
TakedaPreclinical
Sovaldi
GileadPreclinical
Lorelco
SanofiPreclinical
Activase
RochePreclinical
Miochol
BBausch Health Americas, Inc.
Preclinical
Epoetin Beta
RochePreclinical
Januvia
ZZydus Therapeutics Inc.
Preclinical
Baraclude
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Methadone15 trials
Show 12 more trials
Treatment10 trials
Show 7 more trials
Neurocognitive Effects of Opiate Agonist Treatment
Completed·—·Phase 4·NCT01733693·135 enrolled
Opioid Use Disorder6 trials
Post Operative Pain6 trials
The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
Terminated·—·Phase 4·NCT02252432·13 enrolled
Neonatal Abstinence Syndrome5 trials
Treatment of Neonatal Abstinence Syndrome
Completed·—·Phase 4·NCT01723722·40 enrolled
The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
Completed·—··NCT01754324·20 enrolled
72 more indications
Buprenorphine5 trials
Show 2 more trials
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
Completed·—·Phase 1/2·NCT00367302·116 enrolled
Interaction4 trials
Postoperative Pain Control4 trials
Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia
Terminated·—·N/A·NCT01430182·17 enrolled
Cardiac Surgery4 trials
Intravenous Methadone for Sternotomy Pain Control in Cardiac Surgery
Recruiting·—·Phase 3·NCT06728371·86 enrolled
Show 1 more trial
Cancer Pain4 trials
Chronic pain3 trials
Neuropathic Pain3 trials
Postoperative Recovery2 trials
Hysterectomy2 trials
Spinal Fusion2 trials
Breakthrough Pain2 trials
Withdrawal2 trials
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Completed·—·Phase 4·NCT01804075·31 enrolled
Tonsillectomy2 trials
Pediatric Pain Optimization After Tonsillectomy
Completed·—·Phase 2·NCT05244226·66 enrolled
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Recruiting·—·Phase 4·NCT06576830·440 enrolled
Postoperative Analgesia2 trials
Anesthesia2 trials
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Completed·—·Phase 4·NCT03726268·907 enrolled
Neuropathy2 trials
Combination Pain Therapy in HIV Neuropathy
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00863057·15 enrolled
Spine Surgery2 trials
Quality of Recovery2 trials
Opioid Dependence2 trials
Spine Fusion2 trials
Opioid Misuse1 trial
Perioperative Pain Control1 trial
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
Unknown status·UUniversity of Illinois College of Medicine at Peoria·Phase 4·NCT02958566·80 enrolled
Nausea and vomiting1 trial
Head and Neck Cancer1 trial
Cognitive Function1 trial
Scoliosis1 trial
Cardiac Surgical Patients1 trial
Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients
Active, not recruiting·—·Phase 3·NCT05913284·86 enrolled
Postherpetic Neuralgia1 trial
Hepatitis C1 trial
Spinal Cord Injury1 trial
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·N/A·NCT00006448·400 enrolled
Postoperative Pain Relief1 trial
Medication1 trial
After Cardiac Surgery1 trial
Major Abdominal Surgery1 trial
Strabismus1 trial
Efficacy and Safety1 trial
Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain
Unknown status·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT02687347·204 enrolled
Tics1 trial
Pharmacogenetics of Disulfiram for Cocaine
Completed·—·Phase 2·NCT00149630·93 enrolled
Efficacy1 trial
Mechanical Ventilation1 trial
Idiopathic Scoliosis1 trial
IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction
Completed·—·Phase 4·NCT05730920·30 enrolled
Neonatal Opioid Withdrawal Syndrome1 trial
Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Active, not recruiting·AAdvancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program·Phase 3·NCT04214834·189 enrolled
Total Knee Arthroplasty1 trial
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
METHADOSE
NDA NDA017116
Jan 1, 1982
METHADONE HYDROCHLORIDE
NDA NDA021624
Jan 1, 1982
METHADONE HYDROCHLORIDE
NDA NDA006383
Jan 1, 1982
DOLOPHINE HYDROCHLORIDE
NDA NDA006134
Jan 1, 1982
WESTADONE
NDA NDA017108
Jan 1, 1982
METHADONE HYDROCHLORIDE
NDA NDA017058
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Dolophine drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Methadone. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Mu Opioid Receptor Agonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- HHikma Pharmaceuticals LLC