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Data updated: Nov 8, 2026

ZEMBRACE SYMTOUCH (AUTOINJECTOR) (sumatriptan succinate) · TONIX MEDS

Approved 2016-01-28

ZEMBRACE SYMTOUCH (AUTOINJECTOR) is FDA-approved to treat 1 condition (same as ONZETRA XSAIL).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-01-28
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

TONIX MEDS
Active Ingredient: SUMATRIPTAN SUCCINATE

ZEMBRACE SYMTOUCH (AUTOINJECTOR) Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2016 to 2019 · 1 indication expansions
Jun 2019 SUPPL
Efficacy
FDA Letter Label
Mar 2017 SUPPL
Label · Labeling
FDA Letter Label
Jan 2016 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What ZEMBRACE SYMTOUCH (AUTOINJECTOR) Treats

1 indications

ZEMBRACE SYMTOUCH (AUTOINJECTOR) is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ONZETRA XSAIL (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT01381796 PROT-15-NP101-013 Ph 1 completed Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults
NCT00723983 NP101-011 PROT-15-NP101-011 Ph 1 completed Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period
NCT00920686 results posted NXN-188-203 Ph 2 completed Study of NXN 188 for the Treatment of Migraine With Aura
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZEMBRACE SYMTOUCH (AUTOINJECTOR) FDA Label Details

Indications & Usage

FDA Label (PDF)

ZEMBRACE SYMTOUCH (AUTOINJECTOR) is FDA-approved to treat 1 condition — same approved indications as ONZETRA XSAIL.

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Data Sources

FDA Approval: NDA208223 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.