The drug for tardive dyskinesia that finally broke through decades of therapeutic neglect is Ingrezza, known generically as valbenazine. On April 11, 2017, the FDA approved it as the first-ever medication specifically indicated for tardive dyskinesia in adults — a milestone that came after years during which clinicians had essentially nothing targeted to offer patients living with involuntary facial and body movements caused by antipsychotic medications. Just months later, on August 30, 2017, a second drug called Austedo (deutetrabenazine) received its own FDA approval for the same condition, giving patients and prescribers two viable options where none had previously existed. For the estimated 800,000 adults in the United States affected by tardive dyskinesia, these approvals were not abstract regulatory events.
Consider someone like a 68-year-old woman who has taken an antipsychotic for years to manage her bipolar disorder. She develops uncontrollable lip smacking and tongue movements that make it difficult to eat and embarrassing to be around her grandchildren. Before 2017, her doctor could try switching medications, lowering doses, or prescribing off-label drugs with spotty evidence — but there was no treatment designed for what she was actually experiencing. Ingrezza and Austedo changed that equation. This article covers how these two drugs work, what the clinical trial data actually shows, who is most at risk for tardive dyskinesia in the first place, the steep cost of treatment and how to navigate it, important safety warnings that come with both medications, and what the future looks like for people managing this condition long-term.
Table of Contents
- What Is the First FDA-Approved Drug for Tardive Dyskinesia, and How Does It Work?
- What Does the Clinical Evidence Actually Show About Efficacy?
- Who Is Most at Risk for Developing Tardive Dyskinesia?
- How Much Do These Treatments Cost, and Can You Afford Them?
- What Are the Serious Safety Warnings Patients Should Know About?
- Why Did It Take So Long to Get an FDA-Approved Treatment?
- What Does the Future Look Like for Tardive Dyskinesia Treatment?
- Conclusion
- Frequently Asked Questions
What Is the First FDA-Approved Drug for Tardive Dyskinesia, and How Does It Work?
Both Ingrezza and Austedo belong to a class called VMAT2 inhibitors — vesicular monoamine transporter 2 inhibitors, if you want the full name. The mechanism is straightforward in concept: these drugs decrease the amount of dopamine that gets packaged and released into the synapse. Since tardive dyskinesia is thought to result from dopamine receptor hypersensitivity after prolonged antipsychotic use, dialing back dopamine signaling helps reduce the involuntary movements that define the condition. This is a fundamentally different approach from the antipsychotics themselves, which block dopamine receptors directly and can paradoxically worsen or even cause TD over time. Ingrezza was developed by Neurocrine Biosciences and is taken once daily, available in 40 mg and 80 mg capsules. Austedo, manufactured by Teva Pharmaceuticals, is taken twice daily and requires a slower dose titration. While both drugs hit the same molecular target, they are not identical. Deutetrabenazine (Austedo) is a deuterated form of tetrabenazine, an older drug that had been used for Huntington’s chorea.
The deuterium modification slows its metabolism, allowing for more stable blood levels and less frequent dosing compared to its predecessor. In 2023, Ingrezza also received FDA approval for chorea associated with Huntington’s disease, expanding its label beyond TD. It is worth noting what these drugs do not do. Neither Ingrezza nor Austedo cures tardive dyskinesia. They require continuous treatment to maintain symptom reduction. If a patient stops taking the medication, the involuntary movements typically return. This is an important distinction for patients and families who may hear “FDA-approved treatment” and assume it means a permanent fix. It is ongoing management, not a cure — but for many patients, that management is life-changing.
What Does the Clinical Evidence Actually Show About Efficacy?
The pivotal trial for Ingrezza enrolled 225 patients with moderate-to-severe tardive dyskinesia, randomizing them to receive 40 mg, 80 mg, or placebo. Results were measured using the Abnormal Involuntary Movement Scale, or AIMS, which is the standard clinical tool for quantifying involuntary movement severity. By week 48, patients on the 40 mg dose saw their AIMS total score drop by 10.2 points from baseline, while those on 80 mg saw a reduction of 11.0 points. Perhaps more striking was the speed of response: 55 percent of patients experienced clinically meaningful improvement by just week 4 of treatment, approximately 95 percent by week 24, and 97 percent by week 48. Austedo’s approval rested on two Phase III studies — AIM-TD and ARM-TD — both randomized, double-blind, and placebo-controlled. Head-to-head comparisons between the two drugs have not been conducted in a single trial, but the available data suggests similar efficacy in reducing AIMS scores with similar tolerability profiles.
For clinicians deciding between the two, the choice often comes down to practical considerations: once-daily dosing with Ingrezza versus twice-daily with Austedo, potential drug interactions, and insurance formulary coverage. However, these numbers deserve context. Clinical trial populations are carefully selected and monitored in ways that do not always reflect real-world practice. Patients with unstable psychiatric conditions, significant medical comorbidities, or those on complex medication regimens may not respond as cleanly as trial participants did. Furthermore, “clinically meaningful improvement” on the AIMS scale does not necessarily mean complete resolution of symptoms. Many patients see genuine reductions in movement severity that improve their quality of life, but some residual involuntary movements may persist even on treatment.
Who Is Most at Risk for Developing Tardive Dyskinesia?
The populations most vulnerable to tardive dyskinesia overlap heavily with those who visit dementia care clinics and brain health practices. Older adults are at substantially elevated risk. Cumulative rates among elderly patients on antipsychotics are staggering — roughly 25 percent develop TD after just one year of treatment, 34 percent after two years, and 53 percent after three years. Compare that with younger adults, where rates of 20 to 30 percent are seen only after years of chronic antipsychotic exposure. Age is the single strongest risk factor, and it compounds with every additional month on the medication. Women are also at higher risk than men, though the reasons are not entirely understood.
Patients on first-generation (typical) antipsychotics such as haloperidol or chlorpromazine face greater risk than those on second-generation (atypical) agents, although atypicals are not risk-free. This matters because many older adults were started on first-generation antipsychotics years or decades ago and may still be taking them, or they may carry the neurological consequences of past exposure even after switching to newer medications. Globally, the prevalence of tardive dyskinesia among all antipsychotic users sits at approximately 25.3 percent — meaning roughly one in four people taking these medications will develop the condition to some degree. Projections estimate approximately 581,000 patients in the United States will have TD by 2025, including around 188,000 severe cases. For families caring for someone with dementia who also takes an antipsychotic for behavioral symptoms like agitation or psychosis, the risk of TD is not a distant theoretical concern. It is a predictable consequence that should be actively monitored.
How Much Do These Treatments Cost, and Can You Afford Them?
The cost of VMAT2 inhibitors is one of the most significant barriers to treatment. Ingrezza carries an average wholesale price of approximately $5,750 per month for the 40 mg dose and $6,225 per month for the 80 mg dose, with retail prices that can climb to $8,611 per month depending on the pharmacy and region. These are not short-term prescriptions — since TD treatment is ongoing, the annual cost can exceed $69,000 to $103,000 per patient, making it one of the more expensive chronic medications on the market. Neurocrine Biosciences, the maker of Ingrezza, offers a copay assistance program through which eligible patients with commercial insurance may pay as little as $0 out of pocket. Teva offers similar support for Austedo.
These programs can be genuinely helpful for patients with private insurance, but they typically do not apply to those on Medicare, Medicaid, or other government-funded plans — precisely the populations most likely to be older adults with TD. For Medicare patients, the medication falls under Part D, and costs depend on the specific plan, formulary tier, and whether the patient has reached the catastrophic coverage threshold. When weighing Ingrezza against Austedo, cost differences may be marginal for any individual patient since both are premium-priced branded medications with no generic alternatives available. The more relevant comparison is often which drug a patient’s insurance plan covers at a lower tier. A prescriber may prefer one drug clinically but end up prescribing the other because of formulary restrictions or prior authorization requirements. Patients and caregivers should work with their pharmacist and insurance provider to understand true out-of-pocket costs before starting treatment.
What Are the Serious Safety Warnings Patients Should Know About?
Both Ingrezza and Austedo carry an FDA black box warning — the agency’s most serious safety label — regarding the risk of depression and suicidality in patients with Huntington’s disease. While this warning is specifically tied to the Huntington’s population, it reflects the broader pharmacological reality that these drugs reduce dopamine signaling, and dopamine plays a central role in mood regulation, motivation, and reward processing. For patients with a history of depression or suicidal ideation, this warrants careful monitoring regardless of the indication. The connection to dementia care is particularly important. Many patients with dementia experience neuropsychiatric symptoms including depression, apathy, and agitation. Adding a medication that further modulates dopamine in an already vulnerable brain requires clinical judgment and close follow-up.
Prescribers must weigh the benefit of reducing involuntary movements against the possibility of worsening mood or behavioral symptoms. Family caregivers should be told what to watch for — increased withdrawal, expressions of hopelessness, agitation that worsens rather than improves — and given a clear plan for reporting these changes. Other common side effects include somnolence, fatigue, and balance issues, all of which carry additional risk in older adults prone to falls. Drug interactions are another consideration, particularly with strong CYP2D6 inhibitors or inducers, which can affect how these medications are metabolized. Patients who are CYP2D6 poor metabolizers may need dose adjustments. None of these cautions are reasons to avoid treatment when it is genuinely needed, but they are reasons to approach it with open eyes and realistic expectations.
Why Did It Take So Long to Get an FDA-Approved Treatment?
For decades, tardive dyskinesia occupied an uncomfortable blind spot in psychiatry. It was recognized as a serious iatrogenic condition — meaning it was caused by medical treatment itself — yet pharmaceutical investment in finding a solution was minimal. Part of the problem was market perception: drug companies questioned whether a condition caused by other drugs would generate enough prescribing volume to justify development costs. Part of it was scientific: the neurobiology of TD was poorly understood, and early attempts at treatment with agents like vitamin E, benzodiazepines, and anticholinergics produced inconsistent results.
The combined revenue of Ingrezza and Austedo now represents approximately $5 billion annually — with Ingrezza alone generating $2.5 billion in 2025 revenue and guiding toward $2.7 to $2.8 billion in 2026, while Teva projects Austedo could exceed $3 billion at peak sales. In retrospect, the market was always there. What was missing was a viable therapeutic mechanism and the willingness to pursue it through clinical development. The lesson for other undertreated neurological conditions is that commercial potential and unmet need do not always align on the same timeline.
What Does the Future Look Like for Tardive Dyskinesia Treatment?
The current treatment landscape, while dramatically better than it was a decade ago, remains limited to two drugs from the same mechanistic class. If a patient does not tolerate or respond adequately to VMAT2 inhibition, there are no approved alternatives. Research into complementary approaches — including drugs targeting different neurotransmitter systems, neuromodulation techniques, and potential biomarkers for early TD detection — is underway but has not yet produced approved therapies. The hope is that the commercial success of Ingrezza and Austedo will attract more investment into TD research broadly.
For clinicians and caregivers in the dementia space, the more immediate priority is prevention and early detection. Screening tools like the AIMS scale should be used routinely in any patient on antipsychotics, especially older adults. When antipsychotic use is necessary, the lowest effective dose for the shortest necessary duration remains the best strategy for minimizing TD risk. And when TD does develop, patients and families should know that effective treatment exists — imperfect and expensive, but real — and that the era of simply living with uncontrollable movements as an unavoidable cost of psychiatric treatment is, for many people, finally over.
Conclusion
The FDA approval of Ingrezza in April 2017, followed by Austedo just months later, marked the end of a long and frustrating period during which hundreds of thousands of Americans with tardive dyskinesia had no targeted treatment. Both VMAT2 inhibitors have demonstrated strong clinical efficacy, with the vast majority of patients in trials achieving meaningful symptom reduction within the first six months. For older adults, women, and patients on long-term antipsychotics — the very populations most likely to develop TD — these drugs represent a genuine therapeutic advance. But the story is not one of uncomplicated triumph.
Monthly costs that can exceed $8,000, the need for indefinite treatment, black box warnings about depression and suicidality, and the reality that neither drug eliminates TD entirely all temper the narrative. Patients and caregivers should approach these medications as valuable tools within a broader management strategy that includes regular movement screening, thoughtful antipsychotic prescribing, and honest conversations with clinicians about risks, benefits, and costs. The drugs exist. The next step is making sure the people who need them can actually access and afford them.
Frequently Asked Questions
Can tardive dyskinesia go away on its own if you stop the antipsychotic?
In some cases, particularly in younger patients with shorter exposure, TD symptoms may diminish or resolve after discontinuing the causative medication. However, in older adults and those with years of antipsychotic use, TD is often irreversible without treatment. Stopping the antipsychotic is not always safe or practical, especially when it is managing a serious psychiatric condition.
Is one VMAT2 inhibitor better than the other?
No head-to-head clinical trials have directly compared Ingrezza and Austedo, and available evidence suggests similar efficacy and tolerability. The practical differences — once-daily versus twice-daily dosing, specific drug interactions, and insurance coverage — tend to drive prescribing decisions more than clinical superiority.
Can you take Ingrezza or Austedo while continuing your antipsychotic?
Yes. Both drugs were studied in patients who continued their existing antipsychotic regimen, and they are designed to be used alongside ongoing psychiatric treatment. The goal is to treat the TD without disrupting management of the underlying psychiatric condition.
Does Medicare cover these drugs?
Ingrezza and Austedo are generally covered under Medicare Part D prescription drug plans, though coverage varies by plan. Patients may face significant out-of-pocket costs depending on their plan’s formulary tier and cost-sharing structure. Manufacturer copay assistance programs typically do not apply to Medicare beneficiaries, though patient assistance programs based on financial need may be available.
Are there any non-drug treatments for tardive dyskinesia?
No non-pharmacological treatments are currently FDA-approved for TD. Some research has explored deep brain stimulation and botulinum toxin injections for focal symptoms, but these remain investigational or off-label. Lifestyle modifications do not treat TD directly, though stress reduction and good sleep may help reduce symptom severity in some patients.
How quickly will I notice improvement after starting treatment?
In clinical trials of Ingrezza, 55 percent of patients experienced clinically meaningful improvement by week 4. However, maximum benefit may take several months. Approximately 95 percent of patients showed meaningful improvement by week 24. Patients should give the medication adequate time before concluding it is ineffective.
