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Gadobutrol Injection
Gadobutrol Injection is a Gadolinium-based contrast agent Small molecule drug developed by Shanghai Shengdi Pharmaceutical Co., Ltd. It is currently in Phase 3 development for MRI contrast enhancement for diagnostic imaging of the central nervous system, body, and cardiovascular system.
Gadobutrol is a gadolinium-based contrast agent that accumulates in tissues and enhances magnetic resonance imaging (MRI) signal by shortening T1 relaxation time.
Gadobutrol is a gadolinium-based contrast agent that accumulates in tissues and enhances magnetic resonance imaging (MRI) signal by shortening T1 relaxation time. Used for MRI contrast enhancement for diagnostic imaging of the central nervous system, body, and cardiovascular system.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Gadobutrol Injection |
|---|---|
| Sponsor | Shanghai Shengdi Pharmaceutical Co., Ltd |
| Drug class | Gadolinium-based contrast agent |
| Target | Water protons (paramagnetic enhancement) |
| Modality | Small molecule |
| Therapeutic area | Diagnostic Imaging |
| Phase | Phase 3 |
Mechanism of action
Gadobutrol is a macrocyclic gadolinium chelate complex used as an MRI contrast medium. It distributes into the extracellular space and enhances image contrast by paramagnetic effects on nearby water protons, improving visualization of tissues and lesions during MRI examinations. The macrocyclic structure provides high thermodynamic and kinetic stability, reducing gadolinium release.
Approved indications
- MRI contrast enhancement for diagnostic imaging of the central nervous system, body, and cardiovascular system
Common side effects
- Gadolinium retention in tissues
- Nephrogenic systemic fibrosis (NSF) risk in severe renal impairment
- Injection site reactions
- Headache
- Nausea
Key clinical trials
- Dotarem vs Gadobutrol Contrast for Breast MRI (PHASE4)
- A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients (PHASE2, PHASE3)
- Novel Imaging Technique to Assess Gynecologic Cancer (PHASE1)
- A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions (PHASE3)
- A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions (PHASE3)
- Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection
- A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems) (PHASE3)
- Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings (PHASE4)
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:
- Gadobutrol Injection CI brief — competitive landscape report
- Gadobutrol Injection updates RSS · CI watch RSS
- Shanghai Shengdi Pharmaceutical Co., Ltd portfolio CI
Frequently asked questions about Gadobutrol Injection
What is Gadobutrol Injection?
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Related
- Drug class: All Gadolinium-based contrast agent drugs
- Target: All drugs targeting Water protons (paramagnetic enhancement)
- Manufacturer: Shanghai Shengdi Pharmaceutical Co., Ltd — full pipeline
- Therapeutic area: All drugs in Diagnostic Imaging
- Indication: Drugs for MRI contrast enhancement for diagnostic imaging of the central nervous system, body, and cardiovascular system
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing