Are There FDA-approved Antiaging Therapies and Drugs?
What if you could eliminate your biggest risk factor for chronic disease? That risk factor is aging.
The Food and Drug Administration (FDA) has traditionally considered aging a natural process, not a disease. However, the World Health Organization (WHO) and an ever-increasing number of scientists support the viewpoint that aging should be considered a disease that causes other diseases. The WHO describes the process of aging as “… the impact of the accumulation of a wide variety of molecular and cellular damage over time.”
Scientists are investigating biochemical and metabolic changes in the body that contribute to the aging process. You can expect an increase in anti-aging treatments and age management solutions on the horizon.
Antiaging treatments are not focused on superficial wrinkles or adding more muscle to your physique. Instead, they focus on cell senescence (cell aging), genomic instability, and changes to your DNA and epigenome. Antiaging treatments under investigation include:
- Grape seed oil
- Cellular reprogramming
- Gene therapy
- Lengthening telomeres
- Increasing NAD+ levels
- Using intermittent fasting and calorie restriction
- Cellular reprogramming
- Reducing inflammation
The time to start antiaging treatments is now. You won’t know how well antiaging therapies extend your health span and lifespan until you die, but you can tell whether antiaging therapies make you feel better now.
The science of antiaging is in its infancy, but several scientific studies have widespread support, clinical trials are underway, and drugs are seeking FDA approval for a new medical indication—antiaging.
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What Does It Mean to Be FDA Approved?
FDA approval is a process that shows that a medication can be safely used in the United States. A division of the FDA, the Center for Drug Evaluation and Research (CDER), is tasked with overseeing the drug approval process.
FDA approval is a multi-step process that ensures drugs work as they should and that their benefits outweigh their known risks. Drug companies start by determining an effective dose for their medication and then begin safety and effectiveness testing. A team of CDER scientists and physicians reviews the data. If the team determines the drug is safe and effective, treats the medical condition for which it is intended by providing a real health benefit, and manages any risks from taking the drug, the drug can be approved.
By having drugs, follow a specific and detailed approval process, doctors and their patients will have the information they need to prescribe medication safely.
To get a medication FDA-approved, it must effectively treat a disease. The first challenge scientists and pharmaceutical companies face is getting aging classified as a disease. This is harder to do than it would seem at first glance because scientists must agree on biomarkers that are associated with aging and can be tracked to provide evidence that a medication is safely and effectively treating aging.
Metformin is widely recognized as a potential anti-aging drug and was given approval seven years ago to begin clinical trials. Two large prospective placebo-controlled clinical trials to test metformin and its antiaging properties are the Metformin in Longevity Study (MILES) and Targeting Aging with Metformin (TAME). These trials are intended to provide proof of concept for the premise that aging is an appropriate scientific target.
Once these barriers are overcome, drug developers will need to consider how they will develop and produce drugs that will be needed by the entire adult population and not just a subset of people with a certain disease. This huge market would make anti-aging therapies very attractive for venture capitalists, investors, and sponsors.
If the disease-specific requirement is removed (antiaging therapies are expected to target multiple age-related diseases), then these therapies could be considered preventative care, not treatment.
How The FDA Approval Process May Change
Fast-tracking drugs for FDA approval was common during the height of the pandemic. Medications that had the potential to slow, treat, or prevent COVID-19 were needed now, not after a long-drawn-out process. Post-pandemic, there will be a need for global consistency in the inspection and regulation of drug research and development. This could slow the approval process for potential anti-aging therapies.
Promising Antiaging Therapies
Antiaging therapies are entering clinical trials, a step toward FDA approval. Antiaging therapies that target metabolic processes involved in the aging process and are potentially promising include:
- Cell rejuvenation therapies
- Tissue and organ regeneration
- Gene therapy
- Cell reprogramming
- Removing aging cells using senolytics
- Repairing DNA
- Stem cell therapy
Promising Antiaging Drugs
No drugs are currently FDA-approved for a medical indication to treat aging. However, promising antiaging medicine include:1
- Metformin: used to treat type 2 diabetes, inhibits mTOR signaling and protein synthesis, activates adenosine monophosphate-activated protein kinase
- Resveratrol: polyphenol found in red wine, inhibits mTOR through ATP competition
- Rapamycin: used to prevent organ and bone marrow rejection and inhibits mTORC1 activity
- Everolimus: may stop cancer growth, mTOR inhibitor
- Nicotinamide mononucleotide: (NMN), a precursor to NAD+
- Quercetin: a plant pigment and flavonoid, targets senescent (aging) cells
- Dasatinib: used to treat cancer, targets senescent (aging) cells
These medications have the potential to change processes at a cellular level by inhibiting protein synthesis or targeting senescent (aging) cells, unlike procedures that target the outcome of aging, such as surgery. In the future, it may be possible to look good without surgery.
Repurposing FDA-approved Products and Therapies
The National Institutes of Aging in the United States, a component of the National Institutes of Health, is funding clinical trials for interventions that directly investigate the causes of age-related diseases. Researchers are asked to investigate new compounds or repurpose existing drugs, biologics, or supplements that may affect the biochemical changes that are thought to affect age-related pathways.
If potential antiaging therapies could gain FDA approval, clinicians would no longer need to prescribe them off-label. This means better access to safety and effectiveness information for prescribers and patients. It also opens the possibility that these medications would be covered under insurance.
Other Promising Antiaging Treatments
Supplements have the potential for age management but do not go through the FDA approval process.
Commonly used vitamins and supplements recommended for age management include:
- Sermorelin is a growth hormone secretagogue. Sermorelin can increase muscle mass and strength and reduce body fat. However, there is some evidence that increased growth hormone may reduce longevity.2
- Glutathione is a potent antioxidant; glutathione can improve immune function and reduce oxidative stress.
- NAD+ is a universal cellular electron transporter, coenzyme, and signaling molecule that transfers energy from foods to body cells, where it is used for growth and repair.
- Coenzyme Q10 is an antioxidant and mitochondrial cofactor involved in energy conversion in mitochondria. These organelles produce cellular energy.
- Metformin synergy combines the antiaging benefits of metformin with leucine and sildenafil, which act synergistically to reduce body weight and triglycerides by activating SIRT1.
- Shetty AK, Kodali M, Upadhya R, Madhu LN. Emerging Antiaging Strategies – Scientific Basis and Efficacy. Aging Dis. Dec 2018;9(6):1165-1184. doi:10.14336/ad.2018.1026
- Bartke A. Growth Hormone and Aging: Updated Review. World J Mens Health. Jan 2019;37(1):19-30. doi:10.5534/wjmh.180018