In a groundbreaking advancement poised to revolutionize medication adherence, researchers at the Massachusetts Institute of Technology (MIT) have engineered an innovative oral drug delivery system capable of releasing medication gradually over the span of an entire week. Traditional pharmacological regimens, particularly for chronic conditions such as schizophrenia, often require daily dosing, a demanding routine that challenges patients’ consistency and can lead to significant health risks upon nonadherence. To address these concerns, MIT scientists in collaboration with the spinout company Lyndra Therapeutics have developed a star-shaped ingestible capsule designed for once-weekly administration, delivering stable therapeutic drug levels directly from within the stomach.
The technology underlying this oral weekly pill is the result of over a decade of meticulous research and engineering aimed at circumventing the obstacles posed by frequent dosing schedules. The capsule itself resembles a large multivitamin in size but boasts a sophisticated mechanical design: upon ingestion, it unfolds into a star shape comprised of six radial arms. These arms anchor the device within the stomach by remaining too large to pass through the pyloric sphincter, the natural gateway to the intestines, thereby creating a biocompatible depot that releases medication slowly over several days. This mechanism ensures prolonged presence in the gastric environment, circumventing rapid transit into the intestines and enhancing localized drug delivery.
The most recent phase 3 clinical trial focused on schizophrenia, employing risperidone—an antipsychotic drug commonly taken daily to manage this debilitating neuropsychiatric disorder. Conducted across five sites in the United States with 83 enrolled patients, the study evaluated the pharmacokinetics and therapeutic efficacy of the weekly oral capsule formulation, known as LYN-005. Patients who completed the trial took one capsule per week for five consecutive weeks, and plasma drug concentrations were systematically measured to assess drug release dynamics and stability. The trial established that medication levels achieved with once-weekly dosing were not only therapeutically effective but demonstrated less pharmacokinetic variability compared to conventional daily pills.
The capsule’s unique geometry and material composition, informed by mechanical and biomedical engineering principles, are central to its successful function. Initially folded for ease of swallowing, the capsule quickly unfolds upon capsule coating dissolution in the acidic environment of the stomach. The arms, fabricated from biocompatible polymers engineered for controlled biodegradation, maintain structural integrity for approximately seven days. Subsequently, these arms fragment into smaller sections that can safely pass through the digestive tract and be excreted naturally, thereby mitigating any potential risk of gastrointestinal obstruction or discomfort. This design enables sustained drug release while preserving patient safety over prolonged gastrointestinal residency.
By leveraging this prolonged gastric retention, the device establishes a controlled-release drug depot. The risperidone embedded within the arms diffuses at a carefully calibrated rate, maintaining stable plasma concentrations optimal for symptom control. Such consistent drug exposure is crucial for schizophrenia management, as fluctuations can precipitate relapse or aggravate disease severity. The device’s ability to deliver medication orally addresses a significant patient preference barrier, given that alternative long-acting formulations typically require biweekly to bimonthly injections administered by healthcare professionals. This innovation thus expands patient autonomy while preserving therapeutic rigor.
Importantly, the clinical evaluations revealed that the once-weekly capsule was effective at sustaining symptom remission comparable to standard daily dosing, as quantified by the Positive and Negative Syndrome Scale (PANSS) scores. Patients’ clinical symptoms remained stable throughout the study’s duration without evidence of deterioration or breakthrough psychosis. Moreover, the safety profile was favorable, with minimal adverse effects limited primarily to mild and transient gastrointestinal symptoms such as acid reflux and constipation, which resolved with continued use. These findings underscore the capsule’s acceptability and clinical viability as a transformative drug delivery modality.
This research represents a pioneering intersection of mechanical engineering, gastroenterology, and psychiatric medicine, highlighting the transformational potential of advanced drug delivery technologies. The multidisciplinary team, including clinicians, pharmacometrists, and engineers, have meticulously optimized device design, drug loading processes, and clinical protocols to ensure reproducibility and scalability. The implications of this technology extend beyond schizophrenia; the platform offers a generalizable approach for sustained oral delivery of diverse pharmaceuticals that currently rely on frequent dosing schedules, broadening treatment options across multiple therapeutic areas.
The innovation stems from MIT’s rich heritage in biomedical devices, spearheaded by Giovanni Traverso, whose work has progressively matured from proof-of-concept prototypes to clinical-grade products. Notably, the conception of the star-shaped gastroretentive device dates back to 2016, with subsequent refinement enabling the current commercial incarnation. The collaboration with Lyndra Therapeutics has been instrumental in translating academic prototypes into a viable pharmaceutical product, demonstrating the promise of university spinouts in accelerating healthcare breakthroughs.
Looking forward, the research team plans to conduct larger-scale phase 3 trials to validate efficacy and safety further and support regulatory submissions aimed at bringing this therapy to market. Additionally, early-phase studies are underway evaluating the capsule’s application for alternative agents including hormonal contraceptives, indicating the versatility of the platform. Such expansion could significantly alleviate medication adherence challenges in various clinical contexts, transforming oral dosing paradigms with sustained-release, patient-friendly formulations.
The advent of this ingestible, star-shaped capsule embodies a leap forward in personalized and precision medicine, merging engineering innovation with clinical insights to address one of the most stubborn obstacles in chronic disease management: consistent medication adherence. As healthcare systems worldwide grapple with improving patient outcomes and reducing hospitalizations related to nonadherence, technologies of this nature offer a compelling blueprint for the future of therapeutics. By combining ease of use with advanced drug delivery kinetics, this once-weekly oral capsule may soon redefine standards of care for schizophrenia and beyond.
In conclusion, this technological milestone not only validates the feasibility of stomach-resident drug depots but also marks a tangible step toward reducing patient burden and improving long-term treatment success. It exemplifies how cross-disciplinary collaboration can solve complex healthcare challenges through ingenious device engineering, rigorous clinical assessment, and patient-centered design. If future studies uphold these encouraging results, such technologies could herald a new era in oral pharmacotherapy, characterized by sustained delivery, improved adherence, and superior patient quality of life.
Subject of Research: People
Article Title: Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial
News Publication Date: 10-Jun-2025
Image Credits: Adam Glanzman
Keywords: Drug delivery, Drug delivery systems, Pharmaceuticals, Health and medicine, Psychological science, Schizophrenia, Psychotic disorders
