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Dextromethorphan syrup - high dose
Dextromethorphan syrup - high dose is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 1 development.
Dextromethorphan syrup is a small molecule that has been studied in various clinical trials for conditions such as schizophrenia, pain, and postoperative care. It is used as an intervention in these trials, often in combination with other treatments like transcranial direct current stimulation.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Boehringer Ingelheim is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Dextromethorphan syrup - high dose |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) (PHASE1, PHASE2)
- Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children? (PHASE4)
- Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination (PHASE1, PHASE2)
- Study to Investigate Safety With Special Emphasis on ECG Effects and Tolerability After Oral Doses of Dextromethorphan Hydrobromide Monohydrate in Healthy Male and Female Subjects (PHASE1)
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:
- Dextromethorphan syrup - high dose CI brief — competitive landscape report
- Dextromethorphan syrup - high dose updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI
Frequently asked questions about Dextromethorphan syrup - high dose
What is Dextromethorphan syrup - high dose?
Who makes Dextromethorphan syrup - high dose?
What development phase is Dextromethorphan syrup - high dose in?
Related
- Manufacturer: Boehringer Ingelheim — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing