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ODT-PZQ
ODT-PZQ is a Small molecule drug developed by Merck KGaA, Darmstadt, Germany. It is currently in Phase 1 development. Also known as: MSC1028703A.
ODT-PZQ is a small molecule used to treat Schistosomiasis, as indicated by ClinicalTrials.gov. It is administered orally in the form of a tablet, with dosages of 50 mg/kg and 60 mg/kg studied in clinical trials.
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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
Merck KGaA, Darmstadt, Germany 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 | ODT-PZQ |
|---|---|
| Also known as | MSC1028703A |
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- L-PZQ ODT in Schistosoma Infected Children (PHASE3)
- An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni) (PHASE2)
- Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers (PHASE1)
- Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years (PHASE1)
- Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers (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:
- ODT-PZQ CI brief — competitive landscape report
- ODT-PZQ updates RSS · CI watch RSS
- Merck KGaA, Darmstadt, Germany portfolio CI
Frequently asked questions about ODT-PZQ
What is ODT-PZQ?
Who makes ODT-PZQ?
Is ODT-PZQ also known as anything else?
What development phase is ODT-PZQ in?
Related
- Manufacturer: Merck KGaA, Darmstadt, Germany — full pipeline
- Also known as: MSC1028703A
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing