Historically, individuals with ASD were misunderstood and often misdiagnosed. As recently as the mid-twentieth century, autism was believed to be associated with schizophrenia and other mental health disorders ( Evans, 2023 ). People with autism were frequently confined to institutions, where treatments such as insulin shock and early psychotropic drug regimens failed to address the specific traits and behaviors associated with autism spectrum disorder ( Havercamp et al., 2021 ). However, with advances in neurodevelopmental research, the understanding of autism symptomology as well as its prevalence has broadened.

According to the International Classification of Diseases, 11th Revision (ICD-11), diagnostic criteria for ASD social impairments may include inappropriate reactions to verbal or nonverbal communication, compromised speech comprehension, reduced social awareness, impaired sharing of mutual interests, and difficulties establishing peer relationships ( Roy & Strate, 2023 ). Restricted or repetitive behaviors might include an inability to adapt to new encounters or situations, rigorous rule-oriented behaviors, preoccupation with objects, stimuli, or special interests ( Roy & Strate, 2023 : p. 88). These symptoms are generally identified during early childhood ( Roy & Strate, 2023 ).

Parents are generally the first to identify autism symptoms in children. Autism is more prevalent in boys than in girls ( CDC, 2017 ). However, diagnosis is often delayed, as there is no absolute test for diagnosis ( CDER & FDA, 2018 ). Autism is complex and may manifest as a wide array or spectrum of behaviors and developmental impacts. The associated behaviors may include camouflaging, stimming, and self-stimulation ( National Autistic Society, n.d. ). Camouflaging is a means of masking symptoms of autism ( Tubío-Fungueiriño et al., 2020 ). It appears that females are more adept at masking their symptoms than males ( Roy & Strate, 2023 ). Masking and camouflaging have been associated with comorbidities such as depression and stress ( Cook et al., 2021 ). Notably, there are no assessment tools to detect masking. However, recently, researchers have begun to develop questionnaires ( National Autistic Society, n.d. ). Camouflaging can also reduce the appearance of symptoms such as repetitive movements. Stimming or repetitive movements might include rocking, hand flapping, skipping/jumping, repetitive blinking or eye movements, or averted gaze ( Cook et al., 2024 ). This cadre of symptoms could also include repeatedly listening to the same music or videos, touching textures and fabrics, or smelling or chewing objects ( National Autistic Society, n.d. ). Self-stimulatory behaviors are sometimes aligned with hyper-sensitivities, where success in symptom reduction has been achieved through functional communication training ( Ali et al., 2025 ).

The role of the primary caregiver is essential during the intervention and treatment process. Studies have shown that parents who are engaged and trained in treatment expectations exhibit a greater sense of self-efficacy and stress reduction ( Kurz rok et al., 2021 ). Training might include providing caregivers with an understanding of clinical trials for autism symptom relief, as well as the risks and benefits of interventions, clinical research, and symptom management ( Kurz rok et al., 2021 ).

Primary caregivers, along with their support teams (clinicians, pediatricians, speech therapists, etc.), play a vital role in shaping treatment planning and delivery of care for individuals with autism ( Bieleninik & Gold, 2021 ). Given the individual nature of autism symptomology and the absence of a definitive cure, navigating treatment options, evaluating medication efficacy, and engaging with emerging research processes present nuanced and often complex challenges.

Scholars are also of the philosophy that primary caregivers and patient communities should be engaged in the design and implementation of clinical trials and research for autism ( Russell et al., 2017 ). However, this is not always the case. There have been some instances where stakeholder input was excluded from the process even though researchers sought input during the design phase ( Elberse et al., 2011 ). According to Al-Mazidi and Al-Ayadhi (2021) , parents may also grapple with understanding the healthcare therapies and variations of interventions available. Caregivers may also lack knowledge about viable treatment plans and service providers to treat core neurological presentations.

The plethora of information regarding autism interventions may overwhelm caregivers. For example, material regarding autism treatments is disseminated through various channels (e.g., internet, medical pamphlets, video, and digital media), which can complicate caregivers’ ability to assess the most effective medication, application, and determine symptom management ( Grant et al., 2016 ). Importantly, confusion may lie in understanding how some medications only address peripheral symptoms versus the core symptoms, making caregivers vulnerable to the plethora of pharmaceutical marketing strategies (e.g., sensory inputs, related to sound, light, and textures).

Additionally, these parents tend to face three primary challenges: pediatrician knowledge gaps related to autism, communication challenges regarding treatment options, and understanding treatment alternatives ( Al-Mazidi & Al-Ayadhi, 2021 ). As such, at the outset, clear goals should be prioritized as a collaborative process between the treatment provider and primary caregivers ( Roy & Strate, 2023 ). Additionally, caregivers would benefit from understanding the limitations of pharmaceutical-sponsored medications ( Bradshaw et al., 2022 ).

The evolving understanding of autism and its projected prevalence have significantly shaped pharmaceutical market strategies and raised persistent ethical concerns. In recent decades, the projected increase in autism designations in the United States may have influenced the rapid expansion of pharmaceutical industry investments ( Fortune Business Insights, 2025 ). Therapeutic market investments in autism research and development are expected to grow from an estimated $1.93 billion in 2022 to $3.42 billion by 2030 ( Fortune Business Insights, 2025 ). Industry sponsorship ranges from major pharmaceutical companies such as Janssen, Bristol Myers, and Lilly ( Cortesi et al., 2012 ; Hollander et al., 2012 ; Subramanian et al., 2020 ) to academic and emerging biopharmaceutical firms, each with varying ethical standards and research agendas ( Kirino, 2014 ).

In addition to pharmaceutical growth strategies, their marketing efforts are often extensive, promoting claims about the efficacy of certain medications. However, some medications may have undisclosed side effects and are considered toxic ( Autism Research Institute, n.d. ). For instance, both risperidone and aripiprazole have received FDA approval for treating the irritability and aggression associated with ASD, but not its core symptoms. The exaggeration of efficacy is further evidenced by the legal case against Johnson & Johnson, which faced a $2 billion criminal and civil liability suit for improper marketing and misbranding of the antipsychotic drug risperidone. The case highlighted the company’s overstatements regarding the efficacy and intended uses of these medications ( United States Attorney’s Office, Eastern District of Pennsylvania, 2013 ).

There are a growing number of medications and drugs under consideration for FDA approval, yet there remain unresolved ethical concerns around sponsorship and conflicts of interest. Despite growing research efforts, ethical challenges persist, particularly in research involving children with disabilities ( Nisarga et al., 2022 ). Specifically, psychotropic drugs are still being administered, sometimes without a co-occurring professional diagnosis ( Havercamp et al., 2021 ). Moreover, some FDA-approved drugs and medications are associated with consequential side effects on appetite and marked behavioral changes in children ( LeClerc & Easley, 2015 ; McCracken et al., 2002 ).

Multiple studies affirm co-occurring conditions in most individuals with autism. For example, Kerns et al., (2020) found that 78 percent of children with autism had at least one mental health condition, and almost 50 percent had two or more. Conditions cited were ADHD (48 percent), anxiety (roughly 40 percent), and depression (roughly 16 percent) ( Tomiyama, 2025 ).

Table 1 , autism pharmacology: ethical concerns, lists drugs currently receiving research interest and review, including risperidone, aripiprazole (Abilify), fluoxetine (Prozac), melatonin, methylphenidate (Ritalin), leucovorin, cannabidiol (CBD, cannabis), and oxytocin.

As illustrated in Table 1 , risperidone is sponsored by Janssen, approved in 2006. This medication is designed to address targeted symptoms such as mood swings, aggression, and self-injury. However, this medication has limited information on its long-term effects on autistic patients. In some cases, this medication has been dubbed in the pharmaceutical industry as a quick fix or magic pill, yet it offers modest relief from the complexities that fuel distress in the lives of those with Intellectual/Developmental Disabilities (ID/DD) and ASD ( Davico et al., 2023 ).

Aripiprazole ( Table 1 ), also known as Abilify, was approved in 2009 as a medication to address mood swings, aggression, and self-injury as well. The randomized clinical trials extended 8 weeks with a sample of youth ( Kane et al., 2009 ). However, there was no autistic advisory committee input from parents, primary caregivers, or stakeholders, with a noted financial conflict of interest. The sponsor was Bristol-Myers and Squibb.

Note: Off-label: FDA-approved but prescribed off-label for autism.

As illustrated in Table 1 , fluoxetine (Prozac) is an off-label medication sponsored by Lilly and other generic brands. This medication is designed to reduce symptoms related to repetitive behaviors and obsessive-compulsive presentations ( Hollander et al., 2012 ; LeClerc & Easley, 2015 ). Its weaknesses include limited sample size, and it has industry funding, suggesting a potential conflict of interest.

Melatonin ( Table 1 ) is an unregulated supplement used to address sleep disorders. Limited research exists. However, Cortesi et al. (2012) conducted a randomized, placebo-controlled study. There were 160 children aged 4 to 10 with autism. Treatment was administered at controlled times each day. The outcomes showed significant insomnia reduction.

Methylphenidate (Ritalin), as shown in Table 1 , is considered an off-label drug produced by Novartis and Concerta. This medication targets attention regulation disorders and autism comorbidities. Clinical trials were conducted in a children’s hospital in Pennsylvania ( LeClerc & Easley, 2015 ). The ethical concerns include the medications that were designed to address Attention Deficit Hyperactivity Disorder (ADHD). However, methylphenidate was possibly misapplied to address autism traits ( LeClerc & Easley, 2015 ).

As illustrated in Table 1 , leucovorin trials and research have been associated with autism treatment for speech and communication ( Frye et al., 2018 ). This off-label (a medication being used in a manner not officially approved by the FDA) drug has been administered to increase the folate brain level in autistic children. Some participants had cerebral folate deficiencies. Folate autoantibody tests can generally identify children most likely to respond to leucovorin ( Rossignol et. al., 2014 ; Frye et al., 2024 ). The side effects of this therapy were considered mild, but some hyperactivity was experienced. Optimal mitochondrial levels may be needed for this treatment approach ( Hill et al., 2025 ).

Cannabidiol (CBD), as shown in Table l., has received attention from both parent/caregiver experimental use and clinical trials. DeFloria, a partnership between Charlotte’s Web and Anja BioSciences, has progressed to a phase-2 clinical trial for a cannabis-based botanical drug to treat hyperactivity in the ASD community ( Stevens, 2025 ). Caregivers have reported favorable results using CBD oils to reduce stress, aggression, and other behaviors ( Hobbs, 2025 ). These substances contain little Tetrahydrocannabinol (THC) and are not considered psychoactive. However, potential side effects include nausea, drowsiness, and depression ( Stevens, 2025 ).

As illustrated in Table 1 , oxytocin is also related to social functioning and augmented or enhanced brain functioning ( LeClerc & Easley, 2015 ). Researchers found favorable results with emotional regulation variables and eye contact parameters. The nasal spray also had numerous early and mid-stage trials in the U.S. ( LeClerc & Easley, 2015 ); however, clinical trials did not report the inclusion of autism-related participation.

Treatment efficacy related to the two FDA-approved medications aripiprazole and risperidone has shown mixed results. In a placebo-controlled study using a fixed dose of aripiprazole for children and adolescents with ASD and irritability and restricted and repetitive behavior (RRB) symptoms, Marcus et al. (2009) sought to understand the efficacy and short-term relief of symptoms, tolerability, as well as the safe use of aripiprazole. The study duration was 8 weeks. Caregivers completed the Aberrant Behavior Checklist Irritability subscale. The findings showed that aripiprazole was tolerated by affected children’s irritability, with a common side effect of sedation ( Marcus et al., 2009 ).

A 2024 systematic review found that risperidone (Hedges’ g effect size = 0.857; 95% Confidence Interval: −1.263 to 0.451) and aripiprazole (Hedges’ g effect size = −0.559; 95% Confidence Interval: −0.767 to −0.351) outperformed placebos in reducing irritability, aggression, and self-injurious behaviors in autistic youth with high certainties ( Choi et al., 2024 ). These findings suggest that these two pharmaceutical agents may offer meaningful relief for select individuals ( Choi et al., 2024 ). However, such benefits must be assessed against metabolic side effects and long-term treatment, particularly in contexts where medication may be substituted for trauma-informed care and behavioral supports ( Choi et al., 2024 ).

In a meta-analysis examining the efficacy of pharmacological treatments to address symptoms of restricted and repetitive behaviors (RRB), Zhou et al. (2021) critiqued 64 studies (3,499 participants) that used randomized, placebo, clinical trials. The findings showed a small effect size for the efficacy of antipsychotics in improving RRB symptoms. While smaller studies were found to have a larger effect size, the other pharmaceutical treatments did not have a significant effect on reducing RRB symptoms as compared to placebo. For example, oxytocin: SMD = 0.23, 95% CI = −0.01 to 0.47, z = 1.85, p = 0.06 ( Zhou et al., 2021 ). This meta-analysis is significant, being the first comprehensive analysis covering RRB in the literature.

As shown in Table 1 , most of the pharmaceutical compounds discussed fail to progress beyond pre-trial stages, underscoring the significant scientific hurdles and financial risks that can deter further investments. Nevertheless, more treatment data could be gained if greater numbers of clinical trial results were properly reported to the FDA and ClinicalTrials.gov ( Interagency Autism Coordinating Committee, 2022 ).

Additionally, some scholars have raised concerns that the limited commercial incentive associated with inexpensive and widely available medications, such as leucovorin, may reduce pharmaceutical interest in further research or development ( Frye et al., 2018 ; Grounder, 2025 ). To provide better service and treatment options for the autism community, clinical trials need to be inclusive of the spectrum of people affected. The industry should also conduct research for both short- and long-term results, provide clear, best-use guidelines, and cite known risks ( Frye et al., 2024 ). In the interim, the pharmaceutical industry may be marketing metaphoric magic pills, fueled by unchallenged claims.

In light of systemic barriers, restorative frameworks center on the lived experiences of those impacted by overt and unintentional acts (e.g., neurodivergent individuals), fostering inclusive engagement as a pathway to healing those affected ( Suzuki, 2023 ). Flasch (2020) offers that recovery from harm should be viewed as an ongoing endeavor whereby autistic individuals evolve from trauma and exclusionary practices. The utilization of internal and external support can assist in repairing and rebuilding lives post-victimization ( Smith, 2003 ).

Traditional interventions often rely on pharmaceuticals for behavioral control and achievement of ableism goals. However, medicalization may be only temporary fixes that obscure perceived wrongs ( Barbot, 2022 ). Restorative justice challenges these paradigms through 1) Reframing harm not solely as a violation of law, but as a rupture in individual and community trust requiring repair; 2) Centering interventions on the neurodivergent community, which is underrepresented in clinical processes and decision-making; and 3) Ethical matters, which should affirm the autism community in solution participation, who should collaboratively affirm efforts concerning their own health and well-being ( Velez & Gavrielides, 2022 ; Roche, 2003 ; Goldman, 2023 ).

The pharmaceutical industry allocates billions of dollars each year to advertise and conduct research related to autism ( Ramachandran et al., 2021 ). Pharmacological interventions, when carefully prescribed and monitored, can offer relief from co-occurring conditions that exacerbate distress or impair functioning. However, critics argue that pharmaceutical companies prioritize profits over the well-being of patients who often depend on medications ( Baletti , 2023 ). For instance, aggressive marketing campaigns promote prescription drugs for autistic individuals. Statista, a German-founded statistical powerhouse, estimates that the pharmaceutical industry spent $378.5 million on lobbying efforts, demonstrating its influence in U.S. lobbying efforts ( Baletti , 2023 ).

Meanwhile, reforms can be developed to address ethical violations and promote inclusion and community involvement, which are much needed and long overdue ( Castillo & Braslow, 2021 ). The tools for advocacy and change include greater transparency, participatory educational and scientific research, and comprehensive care. A further consideration in unreported clinical processes and results is the absence of participants who align with representation or the needs of the diverse neurodiverse population ( Doyle et al., 2022 ).

Pharmacies and drug stores provide several over-the-counter and prescription-based medication options for the relief of many ailments ( Arta et al., 2025 ). For example, using pharmaceutical interventions, the FDA has approved risperidone and aripiprazole for the treatment of irritability associated with autism spectrum disorder (ASD), primarily in children and adolescents ( LeClerc & Easley, 2015 ; Davico et al., 2023 ). However, as Kirino (2014) and others have noted, no pharmacological intervention has demonstrated efficacy in treating the core features of autism. These medications may alleviate associated behavioral symptoms, but they do not offer curative outcomes. Despite limitations, pharmaceutical trials contribute meaningfully to the field by providing standardized outcome measures, rigorous safety evaluations, and insights into neurohormonal mechanisms ( Manter et al., 2025 ).

The landscape of medications receiving FDA and off-label scrutiny often fails to reveal clinical results or address the complex, multifaceted conditions involved in neurodiversity care ( Durant et al., 2025 ). For example, other co-occurring conditions such as depression, trauma, and chronic pain can also present stemming and social challenges.