What Is Xeomin?
Xeomin is an FDA-approved medication for the temporary improvement of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. It is also used to relieve spasms associated with certain movement disorders like cervical dystonia and blepharospasm.
Known by its generic name IncobotulinumtoxinA, Xeomin is a type of botulinum toxin A. It works by being injected into specific muscles, where it temporarily blocks nerve signals that cause muscle contractions. This action helps to relax the muscles, reducing the appearance of lines or alleviating involuntary spasms.
Beyond its approved uses, Xeomin is currently being investigated in clinical trials for a range of other conditions. These include chronic and episodic migraine, overactive bladder syndrome, and various forms of muscle spasms such as those related to stroke or bruxism (teeth clenching and grinding).
Uses and Conditions Under Study
Xeomin is commonly used to address aesthetic concerns, specifically the appearance of moderate to severe frown lines between the eyebrows, known as glabellar lines. By relaxing the underlying muscles, it helps to smooth these temporary lines. This application is supported by 8 trials, including studies on Glabellar Lines, Glabellar Frown Lines, and Moderate to Severe Glabellar Frown Lines.
The medication is also studied for its ability to manage involuntary muscle contractions. Conditions like Cervical Dystonia, which causes abnormal neck movements and postures, and Blepharospasm, characterized by involuntary eyelid spasms, are being investigated. Additionally, it is explored for Equine and Equinovarus Foot Deformation and severe masticatory muscle spasms (bruxism). In total, 6 trials focus on these types of muscle spasms and dystonias.
Xeomin is being evaluated as a potential treatment for different types of headaches. Clinical trials are exploring its effectiveness in managing Chronic Migraine and Episodic Migraine, with 3 trials dedicated to these conditions. The goal is to reduce the frequency and severity of migraine attacks.
Further research is underway for other neurological and pain-related conditions. This includes studies on muscle spasticity following a Stroke, as well as Notalgia Paresthetica, a sensory neuropathy causing itching and pain in the back. Chemotherapy Induced Peripheral Neuropathy (CIPN) is also being investigated. These areas are covered by 4 trials.
The drug is also being studied for Overactive Bladder Syndrome, a condition causing sudden urges to urinate. 2 trials are investigating whether Xeomin injections can help relax the bladder muscles and reduce symptoms.
Dosing
Xeomin is supplied as a powder that is reconstituted with 0.9% Sodium Chloride (NaCl) to create a solution for injection. It is administered directly into the muscle by a healthcare professional.
Clinical trials have investigated various dosages of Xeomin, depending on the condition being treated. For instance, studies have explored doses such as 50 units for certain muscle injections, or 25 units per eye for conditions like blepharospasm. Other trials have examined doses ranging from 20 units up to 240 units for broader or more severe conditions.
Dilution volumes have also varied, with some trials using high-volume dilutions (e.g., 20 Units/mL) and others low-volume dilutions (e.g., 50 Units/mL). The specific injection sites and the total dose are determined by the treating physician based on the patient's individual needs and the condition being addressed.
Side Effects
In clinical trials, patients receiving Xeomin experienced certain side effects more often than those receiving a placebo. The most commonly reported side effect was dry mouth, affecting 14.9% of patients taking Xeomin, compared to 2.9% on placebo. Other common side effects included:
- Eyelid ptosis (drooping eyelid), reported by 13.6% of patients on Xeomin versus 3.7% on placebo.
- Dysphagia (difficulty swallowing), occurring in 11.6% of patients taking Xeomin compared to 3.7% on placebo.
- Neck pain, experienced by 10.1% of patients on Xeomin versus 4.1% on placebo.
- Dry eye, affecting 10.4% of patients on Xeomin compared to 11.1% on placebo.
- Muscular weakness, reported by 6.3% of patients on Xeomin versus 1.1% on placebo.
- Headache, occurring in 6.6% of patients on Xeomin compared to 4.5% on placebo.
- Musculoskeletal pain, experienced by 5.7% of patients on Xeomin versus 1.4% on placebo.
Clinical Trial Results
Clinical trials have evaluated Xeomin for various conditions, demonstrating its effectiveness in improving symptoms for many patients.
Blepharospasm
In a study (NCT00406367) for blepharospasm (involuntary eyelid spasms), patients treated with Xeomin showed significant improvement compared to placebo. At Week 6 after injection:
- Patients on Xeomin experienced a mean reduction of 0.4 points on the Blepharospasm Disability Index (BSDI), while placebo patients showed a mean increase of 0.11 points. A reduction indicates improvement in disability.
- An independent rater assessed a mean reduction of 0.8 points in severity on the Jankovic Rating Scale (JRS) for Xeomin patients, compared to a mean increase of 0.2 points for placebo.
- Patients treated with Xeomin reported a better overall response to treatment, with a mean score of 1.3 points on the Patient Evaluation of Global Response (PEGR) scale, compared to -0.6 points for placebo.
Cervical Dystonia
For cervical dystonia (involuntary neck muscle contractions), a study (NCT00407030) showed that Xeomin improved symptoms. At Week 4 after injection:
- Patients receiving 120 Units of Xeomin had a mean reduction of 10.8 points in their Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score, compared to a 3.3-point reduction for placebo.
- Patients receiving 240 Units of Xeomin had a mean reduction of 7.3 points in their TWSTRS total score, while placebo patients showed a mean increase of 1.6 points. A reduction in score indicates improvement in symptoms.
- Patients treated with either 120 Units or 240 Units of Xeomin reported a mean global response of 1.3 points, indicating overall improvement, compared to -0.2 points for placebo.
Post-stroke Upper Limb Spasticity
In a study (NCT00432666) on post-stroke upper limb spasticity, Xeomin demonstrated effectiveness:
- At Week 4, 68.5% of Xeomin-treated patients (50 out of 73) experienced at least a 1-point reduction in Ashworth Scale score for wrist flexors, indicating reduced muscle stiffness, compared to 38.4% of placebo patients (28 out of 73).
- For a more significant improvement (at least a 2-point reduction), 19.2% of Xeomin patients (14 out of 73) responded at Week 4, compared to 4.1% of placebo patients (3 out of 73).
- The median time to onset of treatment effect was 4.0 days.
Another study (NCT00465738) comparing two dilutions of Xeomin for upper limb spasticity found that at Week 4:
- 68 participants in the high-volume dilution group and 63 participants in the low-volume dilution group were responders in the Ashworth Scale for wrist flexors.
- Patients experienced an increase in passive range of motion (PROM) for wrist extension, with mean improvements up to 14.8 degrees for the high-volume dilution and up to 15.7 degrees for the low-volume dilution.
Glabellar Frown Lines
A study (NCT00512135) investigating Xeomin for glabellar frown lines (lines between the eyebrows) showed positive results:
- Up to 89.6% of patients were assessed by investigators as responders (showing improvement) at maximum frown.
- Up to 93.8% of patients assessed themselves as responders at maximum frown.
- The onset of treatment effect was generally observed within a few days of injection.
Currently Recruiting Trials
Researchers are actively seeking participants for several clinical trials involving Xeomin and related botulinum toxin treatments. These studies aim to explore new uses and compare effectiveness for a range of conditions, from chronic pain to movement disorders.
For individuals experiencing migraine, there are multiple opportunities. Merz Therapeutics GmbH is sponsoring two large Phase 3 trials: one evaluating Xeomin injections for preventing chronic migraine (NCT07018713), targeting 780 participants, and another for preventing episodic migraine (NCT07018700), aiming for 990 participants. Both studies compare Xeomin to placebo injections in head and neck muscles to measure changes in monthly migraine days. Another Phase 3 study (NCT05598723) is comparing Xeomin to BOTOX® for chronic migraine, with an enrollment target of 128 participants. Additionally, a cohort study (NCT07267819) is examining Xeomin's efficacy for migraines in patients with traumatic brain injuries versus anomalous health incidents, seeking 60 participants.
Beyond migraine, studies are underway for various other conditions. A Phase 3 trial (NCT06995287) is investigating intramyometrial botulinum toxin injections for severe primary dysmenorrhea and chronic pelvic pain, aiming for 222 participants. For those with moderate to severe glabellar lines, a Phase 3 trial (NCT06205797) is comparing HU-045 to Xeomin, with 312 participants. Individuals with degenerative rotator cuff disease and persistent shoulder pain may be eligible for a Phase 2 study (NCT05327972) involving botulinum toxin, with 60 participants. A Phase 4 pilot study (NCT04908423) is exploring Xeomin's association with gait-related mobility after stroke, enrolling 20 participants. For chemotherapy-induced peripheral neuropathy, a Phase 2 study (NCT03571334) is evaluating IncobotulinumtoxinA in 40 participants. A large Phase 3 trial (NCT04075981) is also assessing botulinum toxin injections to prevent atrial fibrillation after cardiac surgery, targeting 220 participants. Finally, a Phase 3 study (NCT03977493) is comparing Xeomin to placebo for focal hand dystonia, seeking 48 participants.
Where to Participate
Clinical trials for Xeomin are conducted across a wide geographic area, with studies taking place at 52 sites in 48 cities across 24 states. This broad reach helps ensure diverse participation in research efforts.
Some of the top locations with multiple active studies include:
- New Haven, Connecticut (4)
- Los Angeles, California (3)
- Little Rock, Arkansas (2)
- Lancaster, California (2)
- Thousand Oaks, California (2)
- Centerville, Ohio (2)
- Phoenix, Arizona (2)
- Frisco, Texas (2)
- McLean, Virginia (2)
- Virginia Beach, Virginia (2)
Eligibility for most Xeomin clinical trials generally requires participants to be between 18 and 89 years of age. Studies typically enroll individuals of all genders, and some may include healthy volunteers. Children are not eligible to participate in these specific trials.
Development Timeline
The journey of Xeomin in clinical research began on December 4, 2006, marking the start of its extensive development. Since then, a total of 41 clinical trials have been initiated, enrolling nearly 8,000 participants in studies exploring its potential.
Early research initially focused on conditions such as irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline significantly expanded, driven by various sponsors, most notably Merz Pharmaceuticals GmbH and Merz Therapeutics GmbH, who have sponsored a combined 15 trials. This expansion led to investigations into a wide array of neurological and aesthetic conditions.
Xeomin's development has progressed through various phases, with the majority of studies reaching advanced stages. There have been 23 Phase 3 trials, 7 Phase 2 trials, and 6 Phase 4 trials, demonstrating a consistent commitment to rigorous evaluation. The scope of research broadened to include conditions like cervical dystonia, chronic migraine, blepharospasm, and moderate to severe glabellar frown lines. Further studies have explored its use in post-stroke upper limb spasticity, focal hand dystonia, primary dysmenorrhea, and even in preventing atrial fibrillation after cardiac surgery, reflecting the versatile therapeutic potential of Xeomin.