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LOY-001 / LOY-003Loyal—LOY-002Loyal—LOY-002Loyal—

LOY-001 / LOY-003

by LoyalUS

PilotStage 3 of 5

LOY-001 (a shot) and LOY-003 (a daily pill for big dogs) have both passed FDA's 'should work' step.

Updated 24d agoChecked 25 Sep0 updates this week

Milestones

Next · Remaining FDA sections
  1. FDA accepts 'should work', a first for lifespan28 Nov 2023Complete.
  2. Remaining FDA sectionsNowCurrent milestone.

Most important updates

  • 24d ago
  • 28 Nov 2023
  • 11 Aug 2023

Physics limits

  • Growth already done can't be undoneBig breeds often live 7-8 years versus 12-15 for small ones. Lowering IGF-1 in adults can only affect what the hormone does later, not the size it already built.
  • IGF-1 also keeps muscle and boneToo little IGF-1 causes muscle loss and frailty. Reduction has to stop around small-dog levels, which caps how much benefit is possible.

How it works

3 parts
An Irish Wolfhound: giant breeds grow big on high IGF-1 and live short lives; LOY-001 and LOY-003 aim to lower it
An Irish Wolfhound: giant breeds grow big on high IGF-1 and live short lives; LOY-001 and LOY-003 aim to lower itPhoto: Jmettlen · CC BY-SA 3.0 (opens commons.wikimedia.org)
Cause

Big dogs make more IGF-1

Large breeds were bred for high levels of IGF-1, a growth hormone. It makes them big but is linked to shorter lives and earlier cancer.

Drug

Lower IGF-1 to small-dog levels

LOY-001, a shot every 3-6 months, and LOY-003, a daily pill licensed from Crinetics, both reduce IGF-1 in adult dogs.

Approval

Conditional FDA path

With the 'should work' section accepted, safety and manufacturing come next; lifespan proof can follow after conditional approval.

Papers & demos

1 item
  1. Nov 2023blog
    FDA CVM RXE acceptance for LOY-001 (opens loyal.com)First sign regulators will judge a lifespan claim.

Update log

3 updates

Wed 16 Sep

  • Major: BlogRegulatory

Tue 28 Nov 2023

  • Major: PressRegulatory

Fri 11 Aug 2023

  • Minor: BlogPartnership

About Loyal

The team behind LOY-001 / LOY-003

Loyal

Lifespan drugs for dogs

San Francisco biotech founded by Celine Halioua making drugs to extend healthy life in dogs, aiming to be the first to win FDA approval for longer life. Its daily pill LOY-002 for senior dogs has two of three key FDA sections accepted.

  • Nov 2023: the FDA's vet center accepted that LOY-001 can reasonably be expected to work: a first for any lifespan drug.
  • Jan 2026: FDA accepted LOY-002's safety section; manufacturing is the last big section before conditional approval.
  • Conditional approval would allow sales while the STAY study of over 1,000 senior dogs continues.

loyal.com (opens loyal.com)Company profile →

Founded
20197 yrs
Headquarters
United States
Status
Private
Valuation
private
Raised
$67M2 rounds
Last round
Financing · $22MFeb 2025
Works in
LongevityPet longevity
Coverage
2 programs · 11 updateslatest 24d agochecked 25 Sep
People
Celine HaliouaFounder and CEO
Primer