Opportunities and Regulatory Challenges for Healthspan Therapeutics

The longevity biotechnology sector is experiencing increasing momentum. Therapeutic interventions targeting healthspan – the period of life spent in good health – are transitioning from basic research to clinical translation, and may well start to be commercialized this decade.

The Minovia Therapeutics SPAC deal, announced June 25, 2025, which values the Haifa-based company at $180 million pre-money, targets rare mitochondrial diseases and age-related decline. Its leadership is connected with Israel’s premier research institutions, including the Hebrew University, the Weizmann Institute, the Israel Institute for Biological Research, and Sheba Medical Center.

The $101 million+ XPRIZE Healthspan challenges competitors to develop therapeutic treatments that significantly extend healthy lifespan by 10 or 20 years by restoring muscle, cognitive, and immune function in individuals aged 65-80, within a treatment period of one year. This unprecedented prize pool has been assembled to incentivize the clinical development of highly robust aging interventions on actionable timelines.

ARPA-H’s PROSPR program in the US seeks contract parties to develop an Intrinsic Capacity composite score measurable at home that predicts long-term health outcomes based on physiological and biochemical measures, and repurposed or new drugs that increase healthspan. Unlike traditional disease-focused initiatives, PROSPR explicitly targets the pre-disease state, where geroscience research suggests the maximum impact for increasing healthspan.

This emerging sector, projected to become a trillion-dollar industry, faces a critical challenge: regulatory frameworks designed for traditional disease-specific therapeutics are not well-equipped to evaluate products targeting mechanisms in the biology of aging.

The Geroscience Revolution

Geroscience – the interdisciplinary field examining the intersection between aging biology and chronic diseases and health – has revealed that aging is not merely an inevitable decline but a malleable biological process. Evidence has been accumulating at an accelerating pace that targeting fundamental aging mechanisms may be able to simultaneously influence multiple age-related conditions, including cardiovascular disease, cancer, neurodegeneration, and metabolic disorders.

This scientific paradigm shift challenges the traditional “one drug, one disease” model that has dominated allopathic pharmaceutical development for decades. Instead of treating individual chronic diseases after they manifest, healthspan therapeutics aim to address their common underlying driver: aging itself.

Regulatory Roadblocks

The regulatory challenges facing healthspan therapeutics are structural and cultural. If a company today approaches the FDA claiming to have developed a pill that “cures aging,” this is unevaluable under current regulations.

Aging is not classified as a disease by regulatory agencies. FDA typically approves treatments for specific diseases in defined patient populations. Healthspan products target multiple chronic diseases across heterogeneous populations.

Moreover, the FDA typically requires a demonstration of clinical benefit in how patients ‘feel, function, or survive.’ This a fortiori limits evaluation of interventions to symptomatic disease states, and creates barriers for upstream interventions targeting molecular or cellular changes in pre-disease states – precisely where geroscience research suggests the greatest impact lies.

Further, vaccines, statins and contraceptives are exceptions that prove the rule, that FDA is not culturally well-equipped to evaluate a preventive therapeutic intervention for healthier, younger people who are not yet patients, and don’t want to be.

And, the timeframes required to demonstrate improved healthspan or longevity in human studies can span decades, creating practical and financial barriers that the private sector typically does not have the ability or stomach to overcome.

Clinical Development Complexities

Beyond regulatory hurdles, healthspan therapeutics face unique clinical development challenges. Traditional clinical trial designs, optimized for acute treatments in symptomatic patients, are poorly suited for interventions targeting healthy aging.

Biomarker validation represents a critical bottleneck. While researchers have identified numerous molecular signatures of aging, translating these into acceptable surrogate endpoints for regulatory development remains a multi-year or multi-decade challenge. The field lacks standardized, validated biomarkers that regulatory agencies will accept as meaningful indicators of healthspan improvement.

Patient recruitment poses additional complexity. Unlike traditional disease-focused trials that enroll patients with clear symptoms, healthspan studies must identify and enroll healthy individuals at risk for age-related decline – a population that may lack motivation or urgency to participate in lengthy clinical trials.

The heterogeneity of aging also presents statistical challenges. Individual variations in genetic background, lifestyle factors, and environmental exposures create substantial noise in clinical outcomes, requiring larger study populations and longer observation periods than traditional trials.

Looking Ahead

The THRIVE Act,* developed by the Kitalys Institute (www.kitalys.org), exemplifies a proposed solution to the regulatory challenge. This draft legislation would establish an optional regulatory pathway, escalating evidentiary requirements and incentives for therapeutic interventions, devices, and supplements targeting healthy longevity. A THRIVE Act version 2.0, incorporating feedback from multiple stakeholders, is now available at www.kitalys.org.

The convergence of advancing geroscience, increasing commercial interest, boosted by GLP-1 drugs, and healthy longevity entering mainstream conversations is driving healthspan products from experimental to mainstream medicine. As the field matures, we can expect standardized biomarkers, novel clinical trial designs, evolving regulatory, reimbursement, and other policies, a multitude of different approaches to increasing healthspan,** and the continuing explosion in longevity medicine. Regulation and policy can accelerate or delay the transition from “sick-care” to precision health, but forward-thinking companies will look for opportunities to get ‘ahead of the curve’ in this inevitable paradigm shift.

* The draft THRIVE Act proposes an optional regulatory pathway for healthspan products (those that can prevent, delay, reduce the risk of, or reverse chronic diseases of aging), with three tiers of escalating evidentiary requirements, and a period of market exclusivity per tier, to incentivize the generation of clinical evidence for extending healthspan. Tier 3 is analogous to full FDA approval, Tier 2 somewhat analogous to Accelerated Approval, and Tier 1 would afford qualifying products earlier access to the market than under current regulations, in order to generate increasingly rigorous clinical data on the capitalization of a commercial-stage company.