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Januvia Tab. 100mg
Januvia Tab. 100mg is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development. Also known as: Sitagliptin 100mg.
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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 | Januvia Tab. 100mg |
|---|---|
| Also known as | Sitagliptin 100mg |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Any Infections And Infestations
- Any Gastrointestinal disorders
- Diarrhoea
- Hypoglycemia
- abdominal distension and abdominal pain 8 cases, dizziness 2 cases, constipation 2 cases
- Nasopharyngitis
- Upper Respiratory Tract Infection
- Any Gastrointestinal Disorders
- Any General Disorders And Administration Site Conditions
- Oedema Peripheral
- Any Musculoskeletal And Connective Tissue Disorders
- Back Pain
Key clinical trials
- Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation (NA)
- Effects of Sitagliptin in Individuals With Genetically Decreased DPP4 (PHASE4)
- iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD) (PHASE3)
- Canagliflozin and Myocardial Fibrosis (PHASE4)
- A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes (PHASE4)
- Comparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients (PHASE3)
- DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes (PHASE4)
- Exploratory Study to Compare the Effects of Tenelia® or Januvia® on Glucose Variability in add-on to Metformin (CGMS Study) (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:
- Januvia Tab. 100mg CI brief — competitive landscape report
- Januvia Tab. 100mg updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about Januvia Tab. 100mg
What is Januvia Tab. 100mg?
Who makes Januvia Tab. 100mg?
Is Januvia Tab. 100mg also known as anything else?
What development phase is Januvia Tab. 100mg in?
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Related
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Also known as: Sitagliptin 100mg