Glabellar LinesPhase 2NCT07321834
A Study to Evaluate AI-09 In Participants With Glabellar Lines
A Phase 2 study testing AI-09 Ready Use Injectable Botulinum Toxin in people with Glabellar Lines, run by Eirion Therapeutics Inc. at 5 sites in United States.
Trial summary
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- AI-09 Ready Use Injectable Botulinum Toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Dec 2025to Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 to 70 years of age
- moderate to severe glabellar lines (IGA 2 to 3) at maximum frown
- moderate to severe glabellar lines (SSA 2 to 3) at maximum frown
- willingness to refrain from the use of facial fillers, retinoids, Botox®, laser
- female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study
- participants should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product
Who cannot join
- the inability to substantially lessen glabellar lines by physically spreading them apart
- eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)
- presence or history of "dry eye"
- history of periocular surgery, brow lift or related procedures, or deep dermal scarring
- concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
- history of immunization or hypersensitivity to any botulinum toxin serotype
Show all 13Show fewer
- history of non-response to any prior botulinum toxin treatments anticipated need for treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment)
- any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- pregnancy or lactation
- application of any topical prescription medication to the treatment area within 14 days prior to treatment
- participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)
- alcohol or drug abuse within the past 3 years
- refusal or inability with the subject's ability to give informed consent or comply with the requirements of the protocol for any reason
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Delricht Research
New Orleans, Louisiana, 70115
Research Your Health
Plano, Texas, 75093
Research Institute of the Southeast, Inc.
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 2, Randomized, Double-blind, Vehicle-Controlled, Multi-Center Clinical Trial Study to Evaluate Ready to Use Injectable AI-09 In Participants With Glabellar Lines
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
Read the detailed description
This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.
- Conditions
- Glabellar Lines
- Being tested
- AI-09 Ready Use Injectable Botulinum Toxin, Vehicle
- Keywords
- Botulinum Toxin, Ready to use, Glabellar Lines, AI-09-GL-201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-09 Ready Use Injectable Botulinum ToxinBiological
AI-09 Ready Use Injectable Botulinum Toxin
VehicleBiological
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | AI-09 Receives: Biological: AI-09 Ready Use Injectable Botulinum Toxin |
| Vehicle | Placebo comparator | Vehicle Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA-C
Change from Baseline (CfB) in IGA-C (Investigator Global Assessment on Contraction) as assessed using the 4-point Glabellar Line Severity Scale (GLS), with score "3" being Severe and score "0" being None.
Measured: From enrollment (baseline) to the Week 04 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start3 Dec 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eirion Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321834
- Sponsor's protocol ID
- AI-09-GL-201
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Vehicle-Controlled, Multi-Center Clinical Trial Study to Evaluate Ready to Use Injectable AI-09 In Participants With Glabellar Lines
- ClinicalTrials.gov ID
- NCT07321834
- Acronym / sponsor ID
- AI-09-GL-201
- Conditions
- Glabellar Lines
- Keywords
- Botulinum Toxin, Ready to use, Glabellar Lines, AI-09-GL-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Eirion Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
Detailed description
This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Biological: AI-09 Ready Use Injectable Botulinum ToxinAI-09 |
| Vehicle | Placebo comparator | Biological: VehicleVehicle |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20 to 70 years of age
- moderate to severe glabellar lines (IGA 2 to 3) at maximum frown
- moderate to severe glabellar lines (SSA 2 to 3) at maximum frown
- willingness to refrain from the use of facial fillers, retinoids, Botox®, laser
- female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study
Key exclusion criteria (13 listed)
- the inability to substantially lessen glabellar lines by physically spreading them apart
- eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)
- presence or history of "dry eye"
- history of periocular surgery, brow lift or related procedures, or deep dermal scarring
- concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-09 Ready Use Injectable Botulinum ToxinAI-09 Ready Use Injectable Botulinum Toxin | Biological | Active Treatment |
| VehicleVehicle | Biological | Vehicle |
Primary outcome
IGA-C
Time frame: From enrollment (baseline) to the Week 04 Visit
Change from Baseline (CfB) in IGA-C (Investigator Global Assessment on Contraction) as assessed using the 4-point Glabellar Line Severity Scale (GLS), with score "3" being Severe and score "0" being None.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AI-09 Ready Use Injectable Botulinum Toxin in people with Glabellar Lines, run by Eirion Therapeutics Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGA-C (time frame: From enrollment (baseline) to the Week 04 Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.