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Canagliflozin tablets
Canagliflozin tablets is a Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 1 development. Also known as: Treatment A (Reference).
Canagliflozin tablets are a small molecule that inhibits the sodium/glucose cotransporter 2, a mechanism used to treat conditions such as type 2 diabetes, hypertension, and chronic kidney disease. They are classified as an inhibitor and have been studied in clinical trials for various indications, including type 2 diabetes and chronic kidney disease.
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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). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Canagliflozin tablets |
|---|---|
| Also known as | Treatment A (Reference) |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Hypoglycaemia
- Urinary Tract Infection
- Oedema Peripheral
- Hypertension
- Blood Creatinine Increased
- Diarrhoea
- Nasopharyngitis
- Hyperkalaemia
- Nausea
- Upper Respiratory Tract Infection
- Anaemia
- Headache
Key clinical trials
- Safety and Efficacy of Canagliflozin in Advanced CKD (PHASE4)
- Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide. (NA)
- Canagliflozin and Myocardial Fibrosis (PHASE4)
- Canagliflozin in Advanced Renal Disease With MRI Endpoints (PHASE2)
- Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer (PHASE2)
- A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus (PHASE3)
- A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure (PHASE3)
- A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (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:
- Canagliflozin tablets CI brief — competitive landscape report
- Canagliflozin tablets updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Canagliflozin tablets
What is Canagliflozin tablets?
Who makes Canagliflozin tablets?
Is Canagliflozin tablets also known as anything else?
What development phase is Canagliflozin tablets in?
What are the side effects of Canagliflozin tablets?
Related
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Also known as: Treatment A (Reference)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing