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SYD-101 0.01%
SYD-101 0.01% is a SGLT2 inhibitor Small molecule drug developed by Sydnexis, Inc.. It is currently in Phase 3 development for Type 2 diabetes. Also known as: atropine sulfate.
SYD-101 is a small molecule that targets the SGLT2 receptor.
SYD-101 is a small molecule ophthalmic solution being studied for the treatment of myopia, or nearsightedness, in children. It is being tested in a multicenter, randomized, double-masked study with concentrations of 0.01% and 0.03% compared to a vehicle control.
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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 | SYD-101 0.01% |
|---|---|
| Also known as | atropine sulfate |
| Sponsor | Sydnexis, Inc. |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
By inhibiting SGLT2, SYD-101 reduces glucose reabsorption in the kidneys, leading to decreased 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
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:
- SYD-101 0.01% CI brief — competitive landscape report
- SYD-101 0.01% updates RSS · CI watch RSS
- Sydnexis, Inc. portfolio CI
Frequently asked questions about SYD-101 0.01%
What is SYD-101 0.01%?
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What is SYD-101 0.01% used for?
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Is SYD-101 0.01% also known as anything else?
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What does SYD-101 0.01% target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Sydnexis, Inc. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Also known as: atropine sulfate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing