Last reviewed · How we verify
SYD-101 0.03%
SYD-101 0.03% is a Antifungal agent Small molecule drug developed by Sydnexis, Inc.. It is currently in Phase 3 development for Fungal skin infections (specific indication under investigation in Phase 3). Also known as: atropine sulfate.
SYD-101 is a topical antifungal agent that disrupts fungal cell membrane integrity.
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 clinical trial at concentrations of 0.01% and 0.03% compared to a vehicle control.
-
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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 0.03% |
|---|---|
| Also known as | atropine sulfate |
| Sponsor | Sydnexis, Inc. |
| Drug class | Antifungal agent |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
SYD-101 is a novel antifungal compound formulated as a 0.03% topical preparation. It is being developed by Sydnexis for the treatment of fungal infections, likely targeting dermatophytes or other superficial fungal pathogens through disruption of fungal cell wall or membrane components.
Approved indications
- Fungal skin infections (specific indication under investigation in Phase 3)
Common side effects
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 0.03% CI brief — competitive landscape report
- SYD-101 0.03% updates RSS · CI watch RSS
- Sydnexis, Inc. portfolio CI
Frequently asked questions about SYD-101 0.03%
What is SYD-101 0.03%?
How does SYD-101 0.03% work?
What is SYD-101 0.03% used for?
Who makes SYD-101 0.03%?
Is SYD-101 0.03% also known as anything else?
What drug class is SYD-101 0.03% in?
What development phase is SYD-101 0.03% in?
Related
- Drug class: All Antifungal agent drugs
- Manufacturer: Sydnexis, Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology/Infectious Disease
- Indication: Drugs for Fungal skin infections (specific indication under investigation in Phase 3)
- Also known as: atropine sulfate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing