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Daily Methadone Dose
Daily Methadone Dose is a opioid Small molecule drug developed by Cari Health Inc.. It is currently in Phase 2 development for opioid use disorder, chronic pain. Also known as: Dose Taken.
opioid receptor agonist
Methadone is a small molecule used to treat opioid dependence and withdrawal syndrome, as well as substance-related disorders. It is administered as part of a therapeutic regimen, often in conjunction with other interventions such as lofexidine or a therapeutic workplace.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | Daily Methadone Dose |
|---|---|
| Also known as | Dose Taken |
| Sponsor | Cari Health Inc. |
| Drug class | opioid |
| Target | mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
Methadone acts as an agonist at the mu-opioid receptor, providing analgesia and reducing withdrawal symptoms in opioid use disorder.
Approved indications
- opioid use disorder
- chronic pain
Common side effects
- nausea
- dizziness
- constipation
Key clinical trials
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
- A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo (PHASE2)
- Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK (EARLY_PHASE1)
- Divided or Single Exposure (DOSE) Study (PHASE2, PHASE3)
- Use of Driving Tests to Evaluate Patient Performance on Oral Opioids
- Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone (PHASE1)
- Treating Polysubstance Use Using a Novel Digital Technology (PHASE3)
- EXHIT ENTRE Comparative Effectiveness Trial (PHASE2, PHASE3)
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:
- Daily Methadone Dose CI brief — competitive landscape report
- Daily Methadone Dose updates RSS · CI watch RSS
- Cari Health Inc. portfolio CI
Frequently asked questions about Daily Methadone Dose
What is Daily Methadone Dose?
How does Daily Methadone Dose work?
What is Daily Methadone Dose used for?
Who makes Daily Methadone Dose?
Is Daily Methadone Dose also known as anything else?
What drug class is Daily Methadone Dose in?
What development phase is Daily Methadone Dose in?
What are the side effects of Daily Methadone Dose?
What does Daily Methadone Dose target?
Related
- Drug class: All opioid drugs
- Target: All drugs targeting mu-opioid receptor
- Manufacturer: Cari Health Inc. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for opioid use disorder
- Indication: Drugs for chronic pain
- Also known as: Dose Taken
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing