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Rocbrutinib tablets
Rocbrutinib tablets is a Small molecule drug developed by Guangzhou Lupeng Pharmaceutical Company LTD.. It is currently in Phase 1 development.
Rocbrutinib tablets are a small molecule intervention used to study the efficacy and safety of treatment in participants with relapse or refractory Mantle Cell Lymphoma. Rocbrutinib tablets are a medication being investigated in a Phase II clinical trial for the treatment of Mantle Cell Lymphoma.
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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).
| 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 | Rocbrutinib tablets |
|---|---|
| Sponsor | Guangzhou Lupeng Pharmaceutical Company LTD. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet (PHASE1)
- A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma (PHASE2)
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:
- Rocbrutinib tablets CI brief — competitive landscape report
- Rocbrutinib tablets updates RSS · CI watch RSS
- Guangzhou Lupeng Pharmaceutical Company LTD. portfolio CI
Frequently asked questions about Rocbrutinib tablets
What is Rocbrutinib tablets?
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What development phase is Rocbrutinib tablets in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing