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LEVOMETHADONE
LEVOMETHADONE is a levomethadone drug. It is currently in Phase 2 development for Opioid dependence.
LEVOMETHADONE works by binding to opioid receptors in the brain, reducing withdrawal symptoms and cravings.
LEVOMETHADONE is a small molecule drug in the levomethadone class, originally developed and currently owned by an unknown entity. It is approved for the treatment of opioid dependence. The commercial status of LEVOMETHADONE is unclear, with unknown patent status and generic manufacturers. LEVOMETHADONE works by interacting with opioid receptors in the brain to reduce withdrawal symptoms and cravings. Key safety considerations include unknown half-life and bioavailability.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | LEVOMETHADONE |
|---|---|
| Drug class | levomethadone |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain has special locks for opioids, and LEVOMETHADONE has a key that fits into those locks. When it binds, it helps reduce the discomfort and urge to use opioids, making it easier to manage withdrawal symptoms and stay on track with treatment.
Approved indications
- Opioid dependence
Common side effects
- Aggression
- Drug abuse
- Logorrhoea
- Patient uncooperative
- Restlessness
- Dysarthria
- Bradyphrenia
- Substance abuse
- Bradykinesia
- Abnormal behaviour
- Drug dependence
Key clinical trials
- Effects of Switching From Racemic Methadone to R-methadone on QTc Intervals (PHASE4)
- Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment
- Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy (PHASE1)
- Completion of OST - a Prospective Study
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LEVOMETHADONE CI brief — competitive landscape report
- LEVOMETHADONE updates RSS · CI watch RSS
Frequently asked questions about LEVOMETHADONE
What is LEVOMETHADONE?
How does LEVOMETHADONE work?
What is LEVOMETHADONE used for?
What drug class is LEVOMETHADONE in?
What development phase is LEVOMETHADONE in?
What are the side effects of LEVOMETHADONE?
Related
- Drug class: All levomethadone drugs
- Therapeutic area: All drugs in Pain
- Indication: Drugs for Opioid dependence
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing