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C213 Microneedle System
C213 Microneedle System is a Transdermal drug delivery system Small molecule drug developed by Zosano Pharma Corporation. It is currently in Phase 2 development. Also known as: Zolmitriptan Microneedle System.
Transdermal microneedle array that delivers drug compounds through the skin for rapid systemic absorption.
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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 | C213 Microneedle System |
|---|---|
| Also known as | Zolmitriptan Microneedle System |
| Sponsor | Zosano Pharma Corporation |
| Drug class | Transdermal drug delivery system |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
The C213 system utilizes a patch containing titanium microneedles that penetrate the stratum corneum to deliver drug formulations into the dermal microcirculation. This delivery method bypasses gastrointestinal absorption and hepatic first-pass metabolism, potentially enabling faster onset and improved bioavailability compared to oral administration.
Approved indications
Common side effects
Key clinical trials
- Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (PHASE2, 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:
- C213 Microneedle System CI brief — competitive landscape report
- C213 Microneedle System updates RSS · CI watch RSS
- Zosano Pharma Corporation portfolio CI
Frequently asked questions about C213 Microneedle System
What is C213 Microneedle System?
How does C213 Microneedle System work?
Who makes C213 Microneedle System?
Is C213 Microneedle System also known as anything else?
What drug class is C213 Microneedle System in?
What development phase is C213 Microneedle System in?
Related
- Drug class: All Transdermal drug delivery system drugs
- Manufacturer: Zosano Pharma Corporation — full pipeline
- Also known as: Zolmitriptan Microneedle System
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing