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In this week’s newsletter

✅ The longevity future is already FDA-approved. ✅ Dietary restriction vs. rapamycin? It’s a tie (sort of). ✅ Rat resuscitation in 2026. ✅ Just another week in AI. ✅ Want to fix the economy? Fix the longevity. ✅ The longevity elite.

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The longevity future is already FDA-approved - it’s just not evenly labeled

For years, the standard line has been: “There are still zero FDA-approved interventions for aging.”
It’s repeated in interviews, echoed in conference keynotes, and, I’ll be the first to admit, I’ve parroted it myself.

But I will be more careful with that line going forward.

According to investor and longevity tracker Karl Pfleger, the first generation of drugs that embody the geroscience paradigm - that is, they treat upstream aging mechanisms rather than downstream disease symptoms - have already been approved by the FDA. They just didn’t arrive under the banner of “anti-aging” or “longevity drug”.

And now, some of them are expanding.

Take vutrisiran (Amvuttra), an RNA-silencing drug from Alnylam. It was initially approved in 2022 for a rare genetic neuropathy caused by misfolded transthyretin (TTR) proteins. But in March 2025, the FDA approved it for cardiomyopathy - same molecule, different organ system, same upstream target: TTR. In other words, one intervention is now cleared to treat two different aging-related pathologies, driven by the same proteinopathy mechanism.

This looks like the beginning of what Pfleger calls “pipeline-in-a-pill” logic: a single drug aimed at a core hallmark of aging can unlock multiple disease indications. The public conversation hasn’t caught up yet - and, more strikingly, even much of the longevity community hasn’t either.

Another example: remestemcel-L (Ryoncil), the first off-the-shelf mesenchymal stem cell therapy* to win FDA approval (December 2024, for pediatric GVHD**). Mesoblast, the company behind it, is now running trials in chronic heart failure and back pain. MSCs target a host of age-related dysfunctions - stem cell exhaustion, chronic inflammation, immune regulation - and these allogeneic stem-cell therapies are now being clinically deployed in the U.S., where the FDA is notoriously conservative on stem-cell approvals.

* If you want to learn more about MSCs, check out our LEVITY episode with Maria Rankka, co-founder of Cellcolabs - whose stated mission is to “revolutionize healthcare by producing cheap and abundant mesenchymal stromal cells”.

** Pediatric graft-versus-host disease (GVHD) is a complication that can occur after a child receives a hematopoietic stem cell transplant (HSCT) from a donor, where the donor's immune cells (graft) attack the child's (host) healthy tissues.

There’s also the underappreciated success story of SGLT2 inhibitors. Originally approved for type 2 diabetes, this class of drugs has since picked up new FDA indications for heart failure and chronic kidney disease. That’s three organ systems, one metabolic lever.

And how about GLP-1? Semaglutide, liraglutide and cousins were born as diabetes drugs, rebadged for obesity (Wegovy, Saxenda) and have since picked up cardiovascular-outcomes, kidney-protection and stroke-reduction data. Now a giant real-world target-trial emulation study of 1.7 million U.S. patients reports a 40–50 % lower incidence of Alzheimer’s-related dementia in those using semaglutide versus other glucose-lowering drugs. That’s metabolic, cardiac, renal and neurodegenerative benefit - all from a single GLP-1 pathway tweak. If SGLT2 inhibitors were the stealth geroprotectors of 2020-24, GLP-1s may be the headline act of 2025-30.

Karl Pfleger includes neither SGLT2 inhibitors nor GLP-1 receptor agonists in his curated roster of ongoing trials and approved drugs, because his list is limited to companies whose primary mandate is targeting core aging biology - a criterion mainstream metabolic blockbusters don’t meet.

Even with that narrow lens, he’s bullish. Speaking at the recent Vitalist Bay conference in Berkeley, Pfleger declared that the “FDA-approved” column on his spreadsheet is about to get crowded and put to rest the idea that aging biology exists solely in the early phases of drug development.

In addition to those mentioned above, three more are in regulatory review (and therefore very likely to be approved soon), with over a dozen others in phase 3 trials. Based on standard success rates, at least seven new approvals can be expected over the next five to ten years.

Of course, no one is pretending you can walk into a pharmacy and buy a longevity pill today. The current crop of FDA-approved gero drugs face serious obstacles:

• Pricing. Vutrisiran costs nearly $500,000 per year.

• Regulatory limits. The FDA still doesn’t recognize “aging” as an indication. That means every new claim (heart, brain, kidney, etc.) requires its own label expansion.

• Diagnostics lag. We still lack validated clinical biomarkers to identify who would benefit most from these interventions, or when to start them.

Even Pfleger admits: “We’re entering a phase where longevity medicine will, for a while, be even more of an art than normal clinical medicine.”

But that doesn’t invalidate the main point: The first approvals are here.

According to Pfleger’s tracker, some promising upcoming approvals target mitochondrial dysfunction, and metabolic regulators like FGF21 and MAS-R agonists. Every one of these has the potential to affect multiple aging-related pathologies.

Meanwhile, calls for a regulatory overhaul must grow louder. If aging were treated as an umbrella indication - like cancer or cardiovascular disease - it could unlock faster trials, broader labels, and value-based pricing models.

Yet the glass is hardly empty. The first wave of longevity drugs has already arrived - proof that the pipeline is real, not hypothetical. As Pfleger reminds us:

“Unless we get regulatory change (such as an accelerated approvals pathway) things will continue to move slowly thru trials, but they are moving. Unless we get 10x gov’t & VC funding the pipeline will be narrower than it should, but it is still big. I’m cautiously optimistic that good things are going to happen in the next 5-10 years.”

News from around the longevity and health space.

Dietary restriction vs. rapamycin? It’s a tie (sort of)

Color me not surprised: A new review of 167 animal studies suggests that one drug - rapamycin - might come close to copy the benefits of eating less. Scientists have long known that cutting calories without causing malnutrition can stretch the lives of lab animals. This meta-analysis found that rapamycin extended lifespan in mice, fish and a few other vertebrates to nearly the same degree as dietary restriction.

Another popular candidate, the diabetes medicine metformin, fared far worse: across the combined data its effect on longevity was small and often indistinguishable from zero.

There are important caveats. When the researchers looked only at studies that reported average (rather than median) lifespans, rapamycin’s advantage disappeared. Most of the evidence also comes from mice, so we still don’t know whether the same payoff would show up in people.

In Time we’ll know if this launch is any good

At LEVITY, big-name outlets start out guilty until proven innocent - at least when they wade into our territory. Now TIME is rolling out Longevity, “a new editorial platform exploring the future of living longer.”

If they tackle the subject with genuine audacity - speaking openly about unlimited lifespans instead of settling for polite “healthy aging” platitudes - I’ll gladly retire my skepticism. But after TIME anointed Seth Rogen as a Time100 Health icon -commendable for his Alzheimer’s advocacy, sure, but not exactly a prophet of radical life-extension - I’m not holding my breath.

The year of the rat

CryoRat - a project I covered in more detail here - just gave us their full two-year plan - and it ends with something, hopefully, historic: an attempt to cryopreserve and revive a mammal. And not decades from now. Next year.

Step by step, the team will test and refine vitrification, organ viability, and recovery protocols in rats - leading up to a full-body sub-zero preservation and resuscitation in 2026.

If successful, it would mark the first true demonstration of reversible cryopreservation in a mammal. The implications? Well, when a 300-gram rodent bounces back from sub-zero, every notion of “irreversible” will be left out in the cold.

Just another week in AI

Day by day, the convergence of AI and biology fills in the missing pieces required for us to take control over our destiny. Three recent releases - one dataset, two foundation models - mark a new milestone in that trajectory.

Xaira’s X‑Atlas/Orion: An 8‑million‑cell Perturb‑seq dataset covering every human protein-coding gene, capturing not just binary gene knockouts but dose-dependent effects - the kind of fine-grained data needed to teach models how real biology responds to intervention. Released publicly under a non-commercial license, it’s a gift to the virtual cell community - and a bold move by a $1B AI biotech aiming to dominate this space.

Arc’s STATE: A foundation model trained on a staggering 270 million single cells, including 100 million perturbation profiles across 70 cell types. Unlike models trained only on observational data, STATE is explicitly designed to predict what happens when you intervene - with a drug, a CRISPR edit, a cytokine - and to model those changes not just in individual cells, but across populations.

DeepMind’s AlphaGenome: A DNA-level model that predicts regulatory function straight from sequence - no wet lab required. It zooms in to the base-pair level to forecast gene expression, enhancer activity, and variant effects, completing the loop between code and function.

Worth your time.

Want to fix the economy? Fix the longevity.

Omri Drory’s new NFX essay, Longevity Can Save America, reframes the usual pro-longevity arguments as a hard-nosed policy brief for Washington. It’s basically the talking points many of us have pushed for years, but wrapped in a “save-the-nation” bow.

What never ceases to amaze me is how clear-cut and rational this case is - yet how stubbornly it fails to register with the people holding the levers of power.

A new AI newsletter that’s probably mostly about longevity

Alex Zhavoronkov is not only the CEO of Insilico Medicine, he’s also a prolific writer. A decade ago he published The Ageless Generation: How Advances in Biomedicine Will Transform the Global Economy, and for years he penned regular columns for Forbes. Now he’s back in the writer’s seat with a new newsletter, Forever.AI, covering AI, robotics, quantum tech, longevity, cryonics, and brain-computer interfaces. If LEVITY is your cup of tea, Forever.AI will fit nicely on the same reading list.

The longevity elite

I haven’t seen this episode yet but resveratrol is on my bingo card. I did, however, sit in on a private Zoom with Peter Diamandis a few days ago. He pitched a $70 000 “Longevity Platinum Trip” investment package. I can’t sell you that - but I can promise you’ll learn far more (for far less) by sticking with LEVITY.

Hey, you’ve made it all the way here! Thank you so much for reading! 🫶🏼