Last reviewed 2026-04-23 · How we verify

M207 Microneedle System

Zosano Pharma Corporation · Phase 3 active Small molecule

M207 Microneedle System is a Transdermal delivery system Small molecule drug developed by Zosano Pharma Corporation. It is currently in Phase 3 development for Migraine (zolmitriptan delivery via microneedle patch). Also known as: ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan.

M207 is a microneedle patch system designed to deliver drugs transdermally by piercing the skin barrier with microscopic needles.

M207 is a microneedle patch system designed to deliver drugs transdermally by piercing the skin barrier with microscopic needles. Used for Migraine (zolmitriptan delivery via microneedle patch).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	M207 Microneedle System
Also known as	ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan
Sponsor	Zosano Pharma Corporation
Drug class	Transdermal delivery system
Modality	Small molecule
Phase	Phase 3

Mechanism of action

The M207 microneedle system uses an array of tiny, solid microneedles to create transient pathways through the stratum corneum, enabling delivery of therapeutic molecules that would otherwise be poorly absorbed through intact skin. This approach bypasses hepatic first-pass metabolism and allows for sustained or controlled release of drugs. The technology platform is being developed to deliver various pharmaceutical agents, with initial focus on peptides and proteins.

Approved indications

Migraine (zolmitriptan delivery via microneedle patch)

Common side effects

Skin irritation at application site
Erythema
Pruritus

Key clinical trials

A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine (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:

M207 Microneedle System CI brief — competitive landscape report
M207 Microneedle System updates RSS · CI watch RSS
Zosano Pharma Corporation portfolio CI

Frequently asked questions about M207 Microneedle System

What is M207 Microneedle System?

M207 Microneedle System is a Transdermal delivery system drug developed by Zosano Pharma Corporation, indicated for Migraine (zolmitriptan delivery via microneedle patch).

How does M207 Microneedle System work?

M207 is a microneedle patch system designed to deliver drugs transdermally by piercing the skin barrier with microscopic needles.

What is M207 Microneedle System used for?

M207 Microneedle System is indicated for Migraine (zolmitriptan delivery via microneedle patch).

Who makes M207 Microneedle System?

M207 Microneedle System is developed by Zosano Pharma Corporation (see full Zosano Pharma Corporation pipeline at /company/zosano-pharma-corporation).

Is M207 Microneedle System also known as anything else?

M207 Microneedle System is also known as ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan.

What drug class is M207 Microneedle System in?

M207 Microneedle System belongs to the Transdermal delivery system class. See all Transdermal delivery system drugs at /class/transdermal-delivery-system.

What development phase is M207 Microneedle System in?

M207 Microneedle System is in Phase 3.

What are the side effects of M207 Microneedle System?

Common side effects of M207 Microneedle System include Skin irritation at application site, Erythema, Pruritus.

Drug class: All Transdermal delivery system drugs
Manufacturer: Zosano Pharma Corporation — full pipeline
Indication: Drugs for Migraine (zolmitriptan delivery via microneedle patch)
Also known as: ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing