Anna's Deep Dives

_{Just facts, you think for yourself}

Aging as a Disease?

Current Regulatory Status and Debates on Classifying Aging

The World Health Organization considered listing aging as a disease in its International Classification of Diseases (ICD). The proposal aimed to replace the vague term “senility” with a medical classification. But after criticism from experts like Kiran Rabheru, the idea was dropped. When ICD-11 was released in 2022, aging was not classified as a disease.

Many oppose this approach. Critics argue it could lead to more ageism in healthcare and society. A global survey showed only 11% of pension fund respondents supported classifying aging as a disease.

Still, a growing number of scientists want to reframe aging as a treatable condition. They argue this would boost funding and help fast-track therapies for age-related decline. With the number of people over 60 projected to rise from 1 billion in 2020 to 2.1 billion by 2050, these questions are gaining urgency.

The U.S. Food and Drug Administration (FDA) has not formally recognized aging as a disease but supports trials targeting its biology. The Targeting Aging with Metformin (TAME) trial, which follows 3,000 people aged 65–79, is testing whether the diabetes drug can delay chronic diseases linked to aging.

Globally, regulatory agencies remain cautious. The European Medicines Agency (EMA) has yet to approve any drug specifically for aging but is monitoring over 25 experimental technologies that may one day fall under this category.

Some countries are adjusting how they fund and classify care. In Australia, the AN-ACC model ties aged care funding to individual need, using a Single Assessment System to determine support. This shifts focus from age alone to functional status.

In the U.S., regulators are pushing to lower out-of-pocket costs for older adults. In 2025, Pennsylvania’s Insurance Department helped residents save $77.2 million on health insurance. These changes reflect a growing effort to improve equity in senior care—regardless of whether aging is formally classified as a disease.

The debate is far from over. Supporters say medical classification could unify research, funding, and treatment efforts. Opponents worry it may stigmatize older people. Either way, regulators must adapt as new aging therapies emerge.

Approaches by FDA, EMA, and Other Global Regulatory Bodies

The FDA has not formally classified aging as a disease but supports research targeting its biology. The TAME trial (Targeting Aging with Metformin) tests whether the drug can delay age-related diseases. Researchers hope it can delay conditions like cancer, Alzheimer’s, and heart disease.

In mice, drugs like rapamycin and trametinib have increased lifespan by over 25%, but these treatments have not been approved for anti-aging use in humans. Most trials still focus on individual diseases.

The EMA is also cautious. In 2025, it reviewed several anti-aging therapies but approved none. It is watching emerging technologies linked to aging but wants more safety and efficacy data. The agency also warns against unapproved treatments like exosome therapies, which some clinics promote without scientific backing.

Both the FDA and EMA face pressure to clarify how they treat aging-related therapies. Many use repurposed drugs—like GLP-1 agonists—approved for other conditions. Off-label use creates shortages and raises access concerns.

Other global regulators are taking diverse approaches. Japan leads in functional food regulation through FOSHU, FNFC, and FFC categories, allowing faster approval for foods with proven health benefits. By 2019, it had 1,721 registered FFC products.

China has not approved aging therapies but invests heavily in biotech. Its elderly population will reach 16% by 2050, up from 10% in 2022. Healthcare gaps between urban and rural regions persist, with a rural care Gini coefficient of 0.31.

Canada supports seniors through its Aging in Place Challenge, using smart home technologies and public-private partnerships to help older adults live independently.

Many aging-related products still enter markets without oversight. Exosome therapies, valued at $256 million in 2023, are not approved by major health agencies, yet clinics continue to offer them. Experts warn that without regulation, unsafe or unproven treatments may proliferate.

Implications for Clinical Trials, Reimbursement, and Patient Access

Treating aging as a disease could change how clinical trials are designed. Most trials now target specific illnesses. If aging were classified as a condition, trials could test therapies that prevent multiple diseases at once.

This would broaden endpoints. Instead of tracking a single disease, trials could measure aging biomarkers or delay in functional decline. The TAME trial uses this approach with metformin, tracking cognitive and cardiovascular outcomes. If successful, it could set a precedent.

Reimbursement systems face similar challenges. Most insurers only pay for treatments tied to recognized diseases. Without formal classification, coverage for anti-aging therapies is limited—even when they improve health. In Belgium, radioligand therapies cost €80,000 and face long reimbursement delays.

Globally, access is uneven. In Europe, only one-third of hospitals can access all approved cancer therapies. Reimbursement delays average 511 days. In Canada, some patients pay out-of-pocket for faster treatment, creating a two-tiered system. If aging therapies follow this pattern, they may benefit the wealthy first.

Some countries are testing new models. Australia’s AN-ACC links care funding to individual need. In the U.S., Pennsylvania’s insurance reforms saved seniors $77.2 million. These examples show how policy can evolve to improve access.

But clarity is key. When aging lacks a regulatory definition, new treatments struggle to gain approval and investment. Some, like exosome therapies, reach markets without oversight, raising safety concerns.

Classifying aging as a disease could open doors to funding, faster trials, and broader insurance coverage. But without careful safeguards, it may also introduce new forms of age-based bias.

Intellectual Property & Patent Strategies

Unique Challenges in Patenting Longevity Therapies

Patenting longevity therapies is not easy. Aging is complex and affects every system in the body. It doesn’t fit neatly into the disease boxes regulators usually work with.

Most countries don’t recognize aging itself as a disease. This creates a barrier for companies trying to patent drugs that target aging broadly. Without a formal indication, therapies must link to specific diseases like Alzheimer’s or cancer to get protection.

Another problem is proving novelty. Many therapies use known drugs like metformin or rapamycin. These already have patents. Companies must find new formulations, delivery methods, or uses to secure new patents, which can be difficult.

Even when patents are approved, enforcement is tricky. Competitors may design around a single patent by slightly tweaking formulas. To counter this, companies build “patent thickets”—overlapping patents on one product. This can block competition, but also raises costs and slows innovation.

Patent coverage varies globally. In the U.S., patents last 20 years and offer strong protection. But in China, enforcement is inconsistent. While China approved over 2.5 million patents in 2019, courts still face backlogs and local bias.

New fields like biomarkers and regenerative medicine bring extra hurdles. For example, plasma tau217 helps detect Alzheimer’s early, but regulators demand high standards of proof. Without global alignment, companies struggle to scale innovations.

Some firms now use alternative strategies. BioNxt Solutions is expanding its patent portfolio by focusing on delivery methods for autoimmune and ovarian aging drugs. Estée Lauder filed a patent on a compound that reduces lipofuscin, or “age pigment,” in the skin.

Startups also face funding pressure. Founders often give up 60–70% of equity to venture capitalists. Many spend more time chasing funds than doing research, weakening control over their intellectual property.

New models like Decentralized Science (DeSci) aim to fix this. VitaDAO raised over $4 million for longevity research by pooling funds from supporters. They tokenize research assets, allowing broader ownership and faster funding—but face legal uncertainty.

Patenting in longevity remains a tightrope walk. Companies must protect their work while navigating laws that lag behind the science. Still, the growth of the $154 billion regenerative medicine market shows progress is possible—if patents, policy, and innovation stay aligned.

IP Battles and How They Shape Innovation

Patent battles are shaping the future of longevity science. They decide who controls key discoveries and who profits from them. These legal fights can protect innovation—or block it.

Pharmaceutical giants often use broad patent portfolios to lock out rivals. Amgen holds at least 68 patents for Enbrel, a drug first approved in 1998. Three still block competitors more than 25 years later. This strategy earned Amgen over $74 billion from a single product.

This approach, called a patent thicket, extends monopolies. Critics say it slows progress and raises prices. New, better treatments must wait until legal barriers fall.

In aging research, these problems are growing. The science moves fast, but the legal system lags. Companies race to patent gene edits, AI drug models, and biomarkers. Ownership disputes can delay trials and stall therapies.

Startups are especially vulnerable. Legal battles drain time and money. In tech, Michael Phillips of Vlingo lost momentum after a patent fight with Nuance in 2008. Instead of building products, he fought lawsuits. Biotech startups in aging face similar risks today.

Japan shows how aging and innovation collide. Over 30% of its population was over 65 in 2021. The country invests in robotics and AI for elder care. But IP laws struggle to keep pace. Disputes over AI-generated inventions are already emerging.

Patent expirations are another pressure. In 2025, over $300 billion in pharmaceutical revenue could vanish as key patents expire. Companies are scrambling to replace them with new assets, pushing over $1 trillion into M&A and new filings.

Copyright battles are rising too. A study found a 35% increase in infringement cases over five years. With AI writing code and lab reports, ownership questions are harder to answer. Many researchers don’t fully understand their IP rights.

The result is tension. Companies want control. Scientists want credit. Patients want access. But the system isn’t built for cooperation.

Licensing, Open-Source Biology, and Collaborative Frameworks

Licensing plays a central role in aging research. It gives companies access to new technologies without building everything from scratch. In 2025, Black Diamond Therapeutics signed a global deal for BDTX-4933, boosting its stock by 65.48%. The drug targets cancer, but the model applies across biotech.

Other firms follow a similar path. Allosteric Bioscience licensed a muscle-preserving drug from Johns Hopkins. About 20% of people over 60 suffer from sarcopenia. This deal helps speed development and reduce risk.

Insilico Medicine partnered with Menarini Group in a $550 million agreement. Their AI-discovered drug earned $20 million upfront, with more to follow as trials progress. Licensing deals like this are reshaping biotech financing.

Open-source biology adds another tool. It encourages data sharing and collaboration. The DO-HEALTH trial, with 2,157 older adults, found that omega-3s slowed aging by 3–4 months and reduced prefrailty by 39% and invasive cancer by 61%. These results came from shared data.

The Stanford 1000 Immunomes Project is also open-access. It tracks immune aging and created the "iAge" model to predict inflammation-based aging. The National Institute on Aging now supports similar public databases.

Decentralized Science (DeSci) is pushing further. VitaDAO raised over $4 million using blockchain to fund longevity research. It lets people invest in early-stage science through digital tokens. Molecule, another DeSci platform, helps researchers tokenize projects to attract global backers.

Still, challenges remain. Many scientists don’t understand blockchain. Tokenized research raises regulatory questions. But the promise is real—faster funding, fewer gatekeepers, and more collaboration.

Policy Proposals & Government Initiatives

Public-Private Partnerships for Anti-Aging Research

Public-private partnerships (PPPs) are reshaping the future of aging research. These collaborations bring together government funding and private-sector innovation. They help speed up discovery, reduce costs, and close healthcare access gaps.

The Alzheimer’s Clinical Trials Consortium (ACTC) runs up to 7 trials across 35 sites in 24 U.S. states. It tests therapies for early-stage Alzheimer’s. The A4 study, part of ACTC, enrolled 1,169 participants to find treatments before symptoms appear.

In the UK, researchers used data from 45,441 participants in the Biobank to develop the ProtAge clock. This tool measures biological age and predicts disease risk. A large gap between biological and real age links to higher early death risk.

Governments are investing directly in aging startups. The State University of New York launched a $6 million fund for biotech companies focused on aging. Japan funds robotics for elder care. Singapore backs aging research as part of its $823.5 billion biotech market.

Some PPPs address life expectancy gaps. Maricopa County and Arizona State University launched a $1 million project to reduce a 14-year lifespan difference between neighborhoods. In Uganda, PPPs in vaccine distribution helped raise life expectancy from 43 in 1991 to 68 in 2024.

In the UK, the government and private developers are building 3,000 low-carbon affordable homes to support senior independence and reduce energy use.

Globally, the U.S. is helping grow biotech in Abu Dhabi through a 150-member delegation, aiming to create an innovation hub focused on longevity and life sciences.

Proposed Legislation and Funding Programs

Governments are rolling out new laws and funding plans to address aging populations. In Canada, the Aging in Place Challenge began in 2021 to help seniors stay in their homes through 2031 using tech and support services.

The U.K. will increase its Disabled Facilities Grant by £86 million in 2025–2026 to help 7,800 people adapt their homes. Total funding to local councils will reach £69 billion, with a 3.5% boost for care reforms.

In the U.S., the Senate supports ongoing funding under the Older Americans Act. The House, however, proposes a $37 million cut to senior nutrition programs that serve many of the 11,000 Americans who turn 65 each day.

The National Academy of Medicine launched the Catalyst Awards, offering fifteen $50,000 grants in 2025. The U.S. Department of Health and Human Services also started the PROSPR program, which funds research on aging-related diseases.

Medicaid, covering 72 million Americans, is under scrutiny. Proposed cuts total $561 billion over nine years. A work requirement bill could remove 600,000 people from coverage. States may face a $43 billion shortfall in 2025 if federal support drops.

These cuts could harm older adults who rely on Medicaid. Loss of coverage may lead to more hospital visits and higher death rates. Advocates warn lawmakers to weigh long-term consequences.

Outside the U.S., countries like Japan and Singapore are expanding support for longevity. Japan funds robotics for elder care. Singapore supports over 70 programs spanning housing, health, and technology for seniors.

Future Directions: Encouraging or Hindering Longevity Innovation?

Governments play a central role in longevity innovation. Some support aging science and tech. Others lag behind as demand rises.

Singapore has over 70 initiatives for its aging population across health, housing, and digital services. By 2030, one in four Singaporeans will be over 65.

Japan invests in automation and AI for elder care. Its over-65 population already exceeds 30% and may reach 35% by 2040.

China has introduced AI tools in senior care. Surveys show 83% of elderly users support these technologies. By the end of 2021, 18.9% of China’s population—267 million people—were over 60.

In the U.S., innovation meets political resistance. Proposed Medicaid cuts could restrict care access for low-income seniors and strain research funding.

Programs like PROSPR aim to protect aging research. But gridlock and healthcare costs could limit their effectiveness.

The U.K. plans to invest £86 million in home adaptations for seniors but still lacks up to 50,000 age-friendly housing units. Without longer-term infrastructure planning, gaps will widen.

A Nature Aging study shows life expectancy gains have slowed. Most countries now add less than 0.2 years annually. The odds of reaching 100 remain below 6% in developed nations.

Key questions emerge: Can policy keep up with science? Can systems support people living longer—but not always healthier?

Innovation needs funding, regulation, and equitable access. Without them, breakthroughs may stall or benefit only the wealthy.

Countries like Singapore, Japan, and China are setting examples. Others risk falling behind. The future of longevity depends on how governments balance bold action with fairness.

We don’t take shortcuts, chase headlines, or push narratives. We just bring you the news, straight and fair. If you value that, click here to become a paid subscriber—your support makes all the difference.

Table of Contents

(Click on any section to start reading it)

Introduction & Foundations of Aging

1. Setting the Stage

   • The grand vision for extending lifespan and healthspan

   • Why is there a “longevity race” now?

2. Historical Perspectives on Aging

   • Early theories and how understanding has evolved

   • Key milestones in gerontology and age-related research

3. Biology of Aging

   • Hallmarks of aging (cellular senescence, telomere attrition, DNA damage)

   • Role of genetics, epigenetics, and environment in aging

Core Interventions – From Caloric Restriction to Epigenetic Reprogramming

1. Caloric Restriction & Dietary Approaches

   • The science behind calorie restriction, intermittent fasting

   • CR mimetics (e.g., resveratrol, rapalogs)

   • Practical applications, controversies, and current clinical evidence

2. Epigenetic Reprogramming

   • Introduction to epigenetics and Yamanaka factors

   • Reversal of cellular aging in model organisms and early human trials

   • Opportunities, risks, and the path to translational therapies

3. Pharmacological & Supplement Strategies

   • Emerging anti-aging compounds (metformin, rapamycin, NMN)

   • Nutraceuticals and their scientific support

   • Off-label uses vs. formal drug development pipelines

The Billion-Dollar Ecosystem & Key Players

1. Biotech Startups in the Longevity Space

   • Profiles of high-profile startups (e.g., Altos Labs, Calico, Life Biosciences)

   • Research focus, funding rounds, and product pipelines

   • Challenges faced by early-stage biotech (R&D timelines, regulatory hurdles)

2. Investment & Funding Landscape

   • Leading venture capitalists, private equity, and philanthropic funding

   • Billionaires backing longevity (e.g., Jeff Bezos, Peter Thiel) and their motives

   • Trends in IPOs, M&A, and public market performance of longevity companies

3. Industry Collaborations & Rivalries

   • Strategic alliances among startups, pharma, and academic institutions

   • Patent landscapes, licensing deals, and joint ventures

   • How competition is driving innovation—and potential duplication of efforts

Societal Impact & Ethical Considerations

1. Moral & Philosophical Questions

   • Is aging a disease that should be cured, or a natural process?

   • Implications of radically extending human lifespans

   • Quality of life vs. longevity trade-offs

2. Social & Economic Ramifications

   • Potential strains on healthcare systems, pensions, and social security

   • Intergenerational equity and shifting demographic structures

   • Wealth disparities in accessing longevity therapies

3. The Global Perspective

   • Cultural attitudes toward aging across different regions

   • Health disparities: Will new therapies exacerbate or reduce them?

   • Possible worldwide collaboration or discord over extended lifespans

Policy & Regulatory Landscape

1. Aging as a Disease?

   • Current regulatory status and debates on classifying aging

   • Approaches by FDA, EMA, and other global regulatory bodies

   • Implications for clinical trials, reimbursement, and patient access

2. Intellectual Property & Patent Strategies

   • Unique challenges in patenting longevity therapies

   • IP battles and how they shape innovation

   • Licensing, open-source biology, and collaborative frameworks

3. Policy Proposals & Government Initiatives

   • Public-private partnerships for anti-aging research

   • Proposed legislation and funding programs

   • Future directions: Encouraging or hindering longevity innovation?

The Road Ahead – Emerging Technologies

1. Next-Gen Therapeutics & Technology

   • Gene editing (CRISPR/Cas9) for senescence and rejuvenation

   • AI-driven drug discovery for personalized anti-aging therapies

   • Organ regeneration, tissue engineering, and other moonshots

2. Predictions & Future Scenarios

   • Short-, medium-, and long-term outlook for practical breakthroughs

   • Potential game-changers—where could the field be in 10–20 years?

   • Risks of hype vs. realistic timelines

Baked with love,

Anna Eisenberg ❤️