Last reviewed · How we verify
MnSOD Mimetic BMX-001
MnSOD Mimetic BMX-001 is a Small molecule drug developed by NRG Oncology. It is currently in Phase 2 development. Also known as: BMX-001, Manganese (III) ortho N-Butoxyethylpyridylporphyrin, Manganese Butoxyethyl Pyridyl Porphyrin, Mitochondrial Manganese Superoxide Dismutatse Mimetic BMX-001.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | MnSOD Mimetic BMX-001 |
|---|---|
| Also known as | BMX-001, Manganese (III) ortho N-Butoxyethylpyridylporphyrin, Manganese Butoxyethyl Pyridyl Porphyrin, Mitochondrial Manganese Superoxide Dismutatse Mimetic BMX-001, Mn(III) meso-tetrakis(N-n-butoxyethylpyridinium-2-yl)porphyrin |
| Sponsor | NRG Oncology |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer (PHASE2)
- Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer (PHASE1, PHASE2)
- Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (PHASE2)
- Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (PHASE1, PHASE2)
- BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer (PHASE1, PHASE2)
- A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy (PHASE1, PHASE2)
- A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer (PHASE1, PHASE2)
- Trial of BMX-001 or Placebo in Head and Neck Cancer Patients (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:
- MnSOD Mimetic BMX-001 CI brief — competitive landscape report
- MnSOD Mimetic BMX-001 updates RSS · CI watch RSS
- NRG Oncology portfolio CI
Frequently asked questions about MnSOD Mimetic BMX-001
What is MnSOD Mimetic BMX-001?
Who makes MnSOD Mimetic BMX-001?
Is MnSOD Mimetic BMX-001 also known as anything else?
What development phase is MnSOD Mimetic BMX-001 in?
Related
- Manufacturer: NRG Oncology — full pipeline
- Also known as: BMX-001, Manganese (III) ortho N-Butoxyethylpyridylporphyrin, Manganese Butoxyethyl Pyridyl Porphyrin, Mitochondrial Manganese Superoxide Dismutatse Mimetic BMX-001, Mn(III) meso-tetrakis(N-n-butoxyethylpyridinium-2-yl)porphyrin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing