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GrantsAbout

2026 Compound

Compound
GrantsAbout
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The rise of OTC and off-label medication
Healthcare

The rise of OTC and off-label medication

Broadening access to medicines + new modalities

Concept

Disease amending therapies, bought over the counter and used off-label will become increasingly common. These medicines are mediated through genetic modification of ‘safe’ bacteria which invokes a regulatory loophole (GRAS approval) or knowledge crowdsourcing for useful (and safe) off-label drugs.

Longer Description

The self-medication movement has been spearheaded by COVID, where patients were incentivized to figure out solutions to their minor illnesses to avoid spaces where they could contract the disease. Contemporaneously, the longevity space has also given credence to science-based self medication, epitomized by Bryan Johnson. Medication and lifestyle amendments has given him the ‘fitness of an 18 year old and the skin of a 28 year old’. Although most people can’t afford a team of 30 medical professionals, like Bryan Johnson, the longevity trend is already producing companies such as AgelessRx which helps in the off-label prescription of Metformin.

At the same time, many drugs (10-20%) are taken off-label and there are new modalities (such as GRAS-approved bacteria) which don’t have have to go through the traditional clinical trial pipeline at a fraction of the cost. The GRAS space is likely to grow more quickly while point cases will expand the use of already approved therapies (Marc Andreessen uses semaglutide off-label). Thus, the venture scale businesses here will either push GRAS approvals for indications or areas (aging, hangovers) of interest or accumulate knowledge of successful use of off-label prescriptions and monetize the dissemination of that knowledge.

Other Thoughts

  • The companies seeking GRAS approval will need multiple products and do undertake smaller-scale trials to prove efficacy (as is seen in cosmetics).
  • Network effects and crowd sourcing will be much more important for off-label companies.

Comparable Companies

  • Zbiotics
  • Unlocked Labs
  • Petri Bio
  • Pendulum
  • Varient App

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2026 Compound