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AJU-S56 5%
AJU-S56 5% is a SGLT2 inhibitor Small molecule drug developed by AJU Pharm Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes. Also known as: Test Group, Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day).
AJU-S56 5% is a small molecule drug that targets the SGLT2 receptor.
AJU-S56 5% is a small molecule being studied for its efficacy and safety in treating Dry Eye Syndromes. The clinical trial, NCT06291194, is evaluating the effectiveness of AJU-S56 5% compared to a placebo after 24 weeks of administration.
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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 | AJU-S56 5% |
|---|---|
| Also known as | Test Group, Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day) |
| Sponsor | AJU Pharm Co., Ltd. |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
By inhibiting SGLT2, AJU-S56 5% reduces glucose reabsorption in the kidneys, thereby lowering blood glucose levels. This mechanism is particularly useful in the treatment of type 2 diabetes.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Diarrhea
- Vomiting
Key clinical trials
- Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients (PHASE2)
- Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients (PHASE3)
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:
- AJU-S56 5% CI brief — competitive landscape report
- AJU-S56 5% updates RSS · CI watch RSS
- AJU Pharm Co., Ltd. portfolio CI
Frequently asked questions about AJU-S56 5%
What is AJU-S56 5%?
How does AJU-S56 5% work?
What is AJU-S56 5% used for?
Who makes AJU-S56 5%?
Is AJU-S56 5% also known as anything else?
What drug class is AJU-S56 5% in?
What development phase is AJU-S56 5% in?
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What does AJU-S56 5% target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: AJU Pharm Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Also known as: Test Group, Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing