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Opioids taper off
Opioids taper off is a Small molecule drug developed by Rigshospitalet, Denmark. It is currently in Phase 3 development for Chronic opioid use disorder with tapering to discontinuation, Chronic pain management with opioid dose reduction. Also known as: Morphine, oxycodone, metadone, fentanyl, tramadol.
A structured tapering protocol that gradually reduces opioid dosing to minimize withdrawal symptoms and dependence while managing pain.
Opioids taper off through interventions such as Treatment as Usual, Telephonic Support, and DOTS Intervention, which are being studied in clinical trials for conditions like Opioid Use Disorder and Opioid Withdrawal. Opioids are small molecules that can be tapered off, as classified by the ChEMBL database, which provides information on their chemical properties and mechanisms.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Opioids taper off |
|---|---|
| Also known as | Morphine, oxycodone, metadone, fentanyl, tramadol |
| Sponsor | Rigshospitalet, Denmark |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Addiction Medicine |
| Phase | Phase 3 |
Mechanism of action
Opioid tapering is a clinical management strategy rather than a pharmacological agent. It involves systematically reducing opioid doses over time to allow the body to adjust and reduce physical dependence. This approach is used to transition patients away from chronic opioid therapy while managing pain through alternative modalities and minimizing acute withdrawal effects.
Approved indications
- Chronic opioid use disorder with tapering to discontinuation
- Chronic pain management with opioid dose reduction
Common side effects
- Withdrawal symptoms (anxiety, insomnia, muscle aches)
- Pain exacerbation during tapering
- Mood disturbances
Key clinical trials
- Preoperative Opioid Tapering Before Spine Surgery (NA)
- Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach (PHASE3)
- Reward-based Technology to Improve OUD Treatment (NA)
- Opioid-Sparing Joint Replacement (PHASE3)
- Evaluating Buspirone to Treat Opioid Withdrawal (PHASE2)
- Patient-Centered Opioid Tapering Study
- Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (PHASE2)
- Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain (NA)
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:
- Opioids taper off CI brief — competitive landscape report
- Opioids taper off updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI
Frequently asked questions about Opioids taper off
What is Opioids taper off?
How does Opioids taper off work?
What is Opioids taper off used for?
Who makes Opioids taper off?
Is Opioids taper off also known as anything else?
What development phase is Opioids taper off in?
What are the side effects of Opioids taper off?
Related
- Manufacturer: Rigshospitalet, Denmark — full pipeline
- Therapeutic area: All drugs in Pain Management / Addiction Medicine
- Indication: Drugs for Chronic opioid use disorder with tapering to discontinuation
- Indication: Drugs for Chronic pain management with opioid dose reduction
- Also known as: Morphine, oxycodone, metadone, fentanyl, tramadol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing