Treatment Adherence And Designing Therapeutics To Meet Patient Needs

By Shalabh Gupta, MD, founder and CEO of Unicycive Therapeutics

When on the quest for treatment solutions and cures, some research teams and developers may not take small side effects and symptoms of patients with chronic illnesses into consideration. Oftentimes, therapies for illnesses like hypertension fail to meet patients where they are, creating an overlooked opportunity to improve patient understanding and innovation. As the complexity of treatment plans continues to grow and overlap, millions struggle to follow prescribed regimens. This is not a behavioral crisis, but rather it’s a signal that our delivery models are misaligned with the lived realities of patients.

Clinical research frequently overlooks the very populations that shoulder the greatest burden of chronic illness. In modern medicine, patients rarely have a single condition; they manage systems of care layered on top of one another. Each added therapy may be clinically justified, but collectively they create a cognitive and logistical load that few health systems formally measure. According to the World Health Organization (WHO), approximately 50% of patients do not take their medications as prescribed, with this percentage being far higher in developing countries.

Changing a factor like pill size or taste may seem like a small solution for treatment burden, but for those who experience treatment daily, it is life-changing. This very idea was the inspiration for the technology used to create Unicycive’s key therapeutic, oxylanthanum carbonate (OLC), to treat hyperphosphatemia in patients with chronic kidney disease. With the goal of meaningful patient adherence, OLC aims to lower the pill burden for patients in terms of the number and size of pills per dose. Rather than forcing patients and their physicians to choose between inadequate treatment options, the goal should always be to support solutions that promote adherence and consistency.

Understanding Treatment Complexity And Adherence

One common application of a pill-based therapy is a regimen of dosages taken twice daily, usually in the morning and at night. Many of us have faced our fair share of poor-tasting medicines or pills that were challenging to get down, but few face true aversion when trying to adhere to a plan. We observed that for those managing their phosphate levels, it is likely that they can take upward of 20 pills a day, with many needing to be taken at specific times for optimal outcomes. Drug non-adherence prevalence in hypertension varies between 55.5% and 46.6%, with only 60% of treated hypertensive patients achieving therapeutic goals.

Further complicating adherence is the varying food requirements and sensitivities across medications, which can be difficult for patients without stable housing to manage, due to their lack of consistent access to storage or regular meals. Language barriers, rising co-pays, and the need to prioritize certain symptoms over others often force patients to make trade-offs that undermine consistent and effective treatment.

Difficulty in treatments complicates adherence. For many patients, sticking to a routine is often out of their hands. Without consistency across patients’ days, it can become nearly impossible to truly plan for proper dedication. If a patient has to commute daily in the mornings, conflicting with the desired window of time recommended by their physician to take their therapy, a change in schedule as small as the morning bus running late can be monumental. Each added requirement in a treatment plan can create another obstacle that stands between a patient and sustained, effective care.

Growing Cumulative Treatment Load

A study shared by the National Library of Medicine found that older adults increasingly deal with multiple chronic conditions. These can include ailments such as hypertension, arthritis, and heart disease. By approaching care from a disease-focused standpoint, complexity remains a primary driver of inequality. Healthcare has engineered therapies for biological efficacy while inadvertently under-engineering them for daily life.

The concurrent use of multiple medications, known as polypharmacy, is one of the most significant yet overlooked risk factors in chronic disease management, increasing the likelihood of drug interactions and unnecessary treatment. Recent data found that this phenomenon is rising. The share of individuals using five or more prescription drugs has grown from 9.2% in 2004 to 11.7% in 2020, heightening risks like hospitalizations.

Often, research can focus on finding an answer rather than truly considering how a treatment fits into a patient’s life, a simple change in mindset that can change the lives of millions. Therapeutics like OLC work to reduce the daily pill burden for those with chronic kidney disease from as many as 15 pills a day to as few as three. These tablets also aim to take other overlooked factors into consideration, such as a smaller size and little aftertaste.

Reformulation To Meet Patient Needs

The power to create responsible, reflective patient trials when developing a new therapeutic lies in much of the groundwork for reducing the burden of consistent adherence. Our strategy was to examine how formulation science can improve both performance and day-to-day use. In many oral therapies, adherence challenges stem from high pill counts, large tablets, poor palatability, and gastrointestinal side effects that accumulate over time.

Addressing those barriers often requires reformulation rather than a new active ingredient. Variables such as dose density, release profile, excipient selection, and tablet compression can materially affect how a product performs in real-world settings. In this case, nanotechnology was used to increase particle surface area and optimize phosphate-binding efficiency, enabling more effective binding in a smaller tablet format. This type of engineering can help lower pill burden while preserving therapeutic activity.

For chronic disease therapies, technical innovation is often most valuable when it improves both pharmacologic function and the practicality of sustained use.

Meeting Patients Where They Are

The endpoint for many researchers drives progress – promising test results or innovations can propel a medication to market. Often, that is where the research ends. Teams consider an aspect of the problem solved.

A patient-first lens helps teams undermine the idea that all patients will act the same. This is a common pitfall in clinical trials that often manifests as increased non-adherence once the treatment is available. In practice, clinical trial settings are carefully structured and closely monitored, with extensive support systems that rarely mirror the realities of everyday life.

People from historically marginalized and economically constrained communities also continue to be underrepresented in trials. That gap limits insight into how treatments truly perform across varied populations and leaves everyday obstacles to consistent use insufficiently understood. Biomarkers and lab values are measured with rigor, but practical considerations such as tablet size, flavor, dosing cadence, or digestive side effects receive far less attention. These details are often decisive in determining whether a therapy can be maintained in real life.

Designing For A More Equitable System

Designing for a more equitable system starts with accepting that scientific progress alone is not enough. A therapy only works if it fits into the rhythm of someone’s actual day – into work schedules, family obligations, limited transportation, and tight budgets. Small details such as how many pills someone has to swallow or whether they can take them without planning their entire day around meals can determine whether treatment is sustained or abandoned. Better outcomes in chronic disease will come from building with real life in mind and judging success by what patients can maintain long after they leave the clinic.

About The Author

Shalabh Gupta, MD, is the founder, president, and chief executive officer of Unicycive Therapeutics, a publicly traded biotechnology company he launched in 2016, where he has advanced a therapy for kidney disease now under FDA review. A physician trained in India who completed his residency and fellowship at NYU, he also holds a Master of Public Administration in Health Care Finance and Management, and previously worked on Wall Street covering pharmaceutical and biotechnology companies. Dr. Gupta is focused on advancing practical, patient-centered innovation in biotechnology.