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AL8326 low dose group
AL8326 low dose group is a SGLT2 inhibitor Small molecule drug developed by Advenchen Pharmaceuticals, LLC.. It is currently in Phase 2 development for Type 2 diabetes.
AL8326 is a small molecule that targets the SGLT2 receptor.
AL8326 is being studied in a Phase 2 clinical trial for the treatment of Small Cell Lung Cancer, Non-Small Cell Lung Cancer, and Renal Cell Carcinoma. The low dose group of AL8326 in this trial is not specified, as the doses studied are 40 mg, 60 mg, and 80 mg.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | AL8326 low dose group |
|---|---|
| Sponsor | Advenchen Pharmaceuticals, LLC. |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 2 |
Mechanism of action
By inhibiting SGLT2, AL8326 reduces glucose reabsorption in the kidneys, lowering blood glucose levels. This mechanism is particularly beneficial for patients with type 2 diabetes. AL8326's effects on blood glucose levels are dose-dependent and may vary across different patient populations.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Diarrhea
- Vomiting
Key clinical trials
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:
- AL8326 low dose group CI brief — competitive landscape report
- AL8326 low dose group updates RSS · CI watch RSS
- Advenchen Pharmaceuticals, LLC. portfolio CI
Frequently asked questions about AL8326 low dose group
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Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Advenchen Pharmaceuticals, LLC. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing