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Hyperpolarized 13-C-pyruvate
Hyperpolarized 13-C-pyruvate is a Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 1 development.
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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 | Hyperpolarized 13-C-pyruvate |
|---|---|
| Sponsor | M.D. Anderson Cancer Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Anosmia
- Dysgeusia
Key clinical trials
- Hyperpolarized Imaging in Diagnosing Participants With Glioma (PHASE1)
- Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma (PHASE1)
- Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
- Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
- Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors (PHASE2)
- Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance (PHASE2)
- Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection (PHASE1)
- Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain 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:
- Hyperpolarized 13-C-pyruvate CI brief — competitive landscape report
- Hyperpolarized 13-C-pyruvate updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about Hyperpolarized 13-C-pyruvate
What is Hyperpolarized 13-C-pyruvate?
Who makes Hyperpolarized 13-C-pyruvate?
What development phase is Hyperpolarized 13-C-pyruvate in?
What are the side effects of Hyperpolarized 13-C-pyruvate?
Related
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing