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Will a senolytic therapy be approved for commercial sale by the United States Food and Drug Administration before January 1 2030?
In recent years, a number of ventures have begun work on translating the results of some promising laboratory studies on senolytic agents into medicine for humans.
A senolytic agent is an agent introduced to the body for the purpose of selectively eliminating senescent cells from the patient. Senescent cells are cells in the body that no longer divide, having reached their Hayflick limit, but which do not automatically apoptose.
These senescent cells linger in the body triggering inflammatory responses, reducing the effectiveness of the immune system, and they are associated with many age-related diseases including type 2 diabetes and atherosclerosis which present a high disease and mortality burden, especially in the most-developed countries in which age-related diseases constitute the overwhelming majority of causes of death among populations.
Senescent cells are thought to play an important part in the aging process, and thus it is theorised that selectively removing these senescent cells would significantly improve healthspan (and perhaps, alone or as part of a combinatorial therapy, significantly extend lifespan).
One major player in this quickly developing area of medicine is Unity Biotechnology. Its pipeline includes several drugs currently in the lead optimization phase, with UBX0101 having this year entered Phase 1 of a randomized, double-blind, placebo-controlled, FDA-approved clinical trial.
You can find out more about these first trials, and more about senolytics in general, here.
This question asks: Will the US FDA (or any US national successor body in the event that the FDA as currently constituted is renamed, reorganized or ceases to exist during the relevant timeframe) approve a product marketed as a senolytic therapy or drug (whether a small molecule drug, gene therapy or other class of clinical intervention) for commercial sale in the United States before January 1 2030?
This question resolves positively in the event that such regulatory approval is granted. Note that the approval must be given before January 1 2030, but the actual sale of any product is not required before that date.
For the purposes of this question, an intervention will be regarded as a 'senolytic therapy' if it is marketed by its producer as an intervention whose purpose includes the selective removal of senescent cells, and medical evidence accepted by the FDA demonstrates that it does so.
The question resolves negatively if no such therapy is approved, and resolves ambiguously if the FDA is disbanded before any approval is given and/or no agency of the US government with the responsibility for granting regulatory approval for drugs and medical interventions is created to succeed it during the relevant timeframe.
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