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BP31510 monotherapy
BP31510 monotherapy is a Small molecule drug developed by BPGbio. It is currently in Phase 1 development.
BP31510 monotherapy has been studied in clinical trials for metastatic cancer, cancer, solid tumor, and pancreatic cancer. The exact mechanism of action of BP31510 is not specified in the provided facts, but it is known to be a nanosuspension injection of ubidecarenone, USP.
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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 | BP31510 monotherapy |
|---|---|
| Sponsor | BPGbio |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients (PHASE2)
- BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors (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:
- BP31510 monotherapy CI brief — competitive landscape report
- BP31510 monotherapy updates RSS · CI watch RSS
- BPGbio portfolio CI
Frequently asked questions about BP31510 monotherapy
What is BP31510 monotherapy?
Who makes BP31510 monotherapy?
What development phase is BP31510 monotherapy in?
Related
- Manufacturer: BPGbio — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing