Xanomeline/trospium chloride (Cobenfy) is a new class of medication that can help reduce symptoms and complications associated with schizophrenia. It may be a promising treatment for people who do not tolerate traditional medications.

Cobenfy gained FDA approval in September 2024. It is the first novel medication therapy approved for schizophrenia since medications to treat the condition became the standard of care decades ago.

Keep reading for more information about what Cobenfy is, how it works, when a doctor may prescribe it, possible side effects, and more.

Cobenfy is a combination of xanomeline and trospium. Karuna Therapeutics developed the medication, which became available in September 2024Trusted Source. Bristol Myers Squibb has since acquired Karuna Therapeutics and will produce Cobenfy going forward.

This treatment is a new class of medication that targets cholinergic receptors instead of dopamine receptors in the brain.

The FDA based its approval on the findings of two identical clinical trials. Researchers found that the new medication was safe and effective for treating schizophrenia.

Novel therapies like Cobenfy may help to reduce symptoms and complications associated with schizophrenia.

Schizophrenia is an uncommon mental health disorder, affecting about 0.25% to 0.64%Trusted Source of the population of the United States. Globally, it affects about 1%Trusted Source of the total population.

Despite its low prevalence, it is in the top 15 mental health disorders responsible for disability across the world. Additionally, about 5% to 10%Trusted Source of people living with the condition die by suicide.

The combination of xanomeline and trospium works on the cholinergic receptors, which play important roles in the somatic and autonomic nervous systems.

There are two types of cholinergic receptors: nicotinic and muscarinic. This medication works by activating muscarinic receptors, which increases their activity. This can reduce the severity of schizophrenia.

Cholinergic receptors also playTrusted Source a role in the dopamine reward system pathway. Therefore, by targeting the cholinergic receptors, the medication indirectly affects dopamine receptors.

The majority of medications used to treat schizophrenia directly target dopamine receptors. By switching the focus of treatment, the makers of Cobenfy hoped to improve therapeutic effectiveness and reduce the side effects associated with traditional medications for schizophrenia.

Researchers testedTrusted Source the effectiveness of Cobenfy in two identical clinical trials. To measure the effectiveness, they used the Positive and Negative Syndrome Scale (PANSS) score at the end of the 5-week trial.

PANSS includes 30 items graded with a score from 1 to 7. Healthcare professionals, researchers, and others use this tool to score the severity of schizophrenia symptoms.

The clinical trials showed that people taking Cobenfy had a meaningful reduction in PANSS score compared with people in the control group.

Clinical trials of Cobenfy found several side effects that occurred in people taking the medication. Some common symptoms includeTrusted Source:

  • constipation
  • nausea
  • vomiting
  • abdominal pain
  • indigestion
  • diarrhea
  • gastroesophageal reflux disease
  • hypertension
  • tachycardia, or increased heartbeat
  • dizziness

Cobenfy may also cause urinary retention and angioedemaTrusted Source (swelling that occurs beneath the skin of the face and lips).

In clinical trials, the side effects were generally mild and did not lead to any patients discontinuing the medication.

As with any other medications, side effects are legitimate concerns. It is crucial for a person with schizophrenia to discuss them with their doctor. It is also important to consider whether the benefits of the new medication outweigh the side effects in the context of treatment goals.

Cobenfy is an oral medication. Dosing is shown as milligrams (mg) xanomeline/mg trospium chloride.

The starting dose is 50mg/20mg. After 2 days, a person may increase the dose to 100mg/20mg.

Once a person is on the higher dose for at least 5 days, a healthcare professional may increase the dose, as tolerated, to 125mg/30mg.

Cobenfy is taken twice a day: one capsule in the morning and one in the evening before bed. A person should take the medication on an empty stomach, at least 1 hour before a meal or 2 hours after a meal.

Taking too much of the medication may cause increased side effects. It is important that a person discusses dosing with a qualified healthcare professional and follow their recommendations.

Doctors or other qualified healthcare professionals may prescribe Cobenfy for people who have not responded well to other medications or who experienced too many intolerable side effects from those medications.

Cobenfy also has some warnings against useTrusted Source in certain populations.

Due to the potential risk of liver damage, people with even mild liver impairment should not take Cobenfy. A person should discontinue use if they develop signs of severe liver issues, such as yellowing of eyes or skin, darkened urine, or unexplained itchiness.

Other people who should not take Cobenfy include those with:

  • untreated narrow-angle glaucoma
  • urinary retention
  • gastric retention
  • moderate or severe kidney or liver disease
  • history of hypersensitivity to the components of Cobenfy

Schizophrenia often requires several modes of treatment. The focus of treatment is to reduce symptom severity, improve day-to-day functioning, and help a person achieve their goals in life.

Some common forms of treatment includeTrusted Source:

  • psychosocial treatments — help with challenges of everyday life and managing symptoms
  • anti-psychotics — the primary medication to treat symptoms
  • coordinated specialty care — recovery-based programs for people after they experience their first episode of psychosis
  • education and support
  • treatments to help reduce drug or alcohol use
  • assertive community treatment — treatments aimed to help people at high risk of repeated episodes of psychosis and homelessness

Cobenfy is a novel treatment option for people living with schizophrenia. The medication works differently than other medications used to treat the mental health disorder.

Cobenfy is generally considered to be safe and effective, and side effects are generally mild. However, not everyone with schizophrenia can take Cobenfy. Most notably, people with liver or kidney issues should avoid the medication.

People living with schizophrenia or their caregivers may want to discuss the possible use of Cobenfy with a qualified healthcare professional.