JUV-161 by Juvena Therapeutics: status and timeline

JUV-161

Restore muscle mass and function in sarcopenic and dystrophic patients using engineered proteins, addressing the unmet need in age-related and genetic muscle diseases.

PilotStage 3 of 5

Phase 1 trial ongoing for muscle atrophy; orphan drug designation for DM1.

Updated 12 Jan 2026Checked 11 Oct0 updates this week

Milestones

Next · Phase 1 clinical trial initiation (ULLI study NCT07397468)

FDA Orphan Drug designation for DM12024Complete.
Phase 1 clinical trial initiation (ULLI study NCT07397468)Target 2025Current milestone.
Phase 1 trial completion targetTarget 30 May 2026Not yet reached.

Most important updates

Upcoming

2025Phase 1 clinical trial initiation (ULLI study NCT07397468) (next)
30 May 2026Phase 1 trial completion target

Current obstacles

Efficacy in sarcopenic patientsCurrent trials in healthy volunteers must translate to elderly or diseased populations where muscle atrophy is more severe and may have multiple causes.
Safety profile in long-term useDemonstrating that weekly or monthly dosing is safe and well-tolerated for chronic use remains a trial priority.

Physics limits

Protein stability and pharmacokineticsEngineered proteins face challenges in half-life and tissue distribution; frequent dosing or depot formulations may be needed for practicality.
Systemic effects beyond muscleIGF2 signaling occurs across many tissues; off-target effects, especially on glucose metabolism and cancer risk, require careful monitoring.

How it works

2 parts

Mechanism

AKT signaling agonist for muscle growth

JUV-161 activates AKT signaling, promoting muscle protein synthesis and strength while counteracting disuse atrophy.

DM1 Target

Myotonic dystrophy type 1

DM1 causes progressive muscle weakness. JUV-161 targets muscle-mass loss, a core problem existing treatments do not address.

Update log

2 updates

Mon 12 Jan

Major: Juvena Therapeutics closes $33.5M Series B led by Bison Ventures with Eli Lilly partnershipPressFunding

Mon 19 May 2025

Major: Juvena begins enrolling Phase 1 trial of JUV-161 in healthy volunteersPressTest

About Juvena Therapeutics

The team behind JUV-161

Juvena Therapeutics

JUV-161 muscle regeneration, JUV-112 obesity

Juvena Therapeutics develops engineered proteins from stem cell secretomes for tissue regeneration. Lead program JUV-161 is in Phase 1 for muscle atrophy. Eli Lilly partnership values $650 million collaboration focused on frailty and obesity.

JUV-161 is in Phase 1 trials for muscle regeneration with an orphan designation for myotonic dystrophy.
Eli Lilly partnership worth $650M targets frailty and obesity using Juvena's AI-driven discovery platform.
JUV-112 preclinical candidate promotes fat breakdown without appetite suppression or muscle loss.

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

Founded: 20179 yrs
Headquarters: United States
Status: Private
Valuation: private
Raised: $75M2 rounds
Last round: Series B · $34MJan 2026
Works in: LongevityAnti-aging drugs
Coverage: 2 programs · 2 updateslatest 12 Jan 2026checked 11 Oct
Lead investors: Bison Ventures
Partners: Eli Lilly and Company (opens lilly.com)
People: Hanadie YousefCo-founderJeremy O'ConnellCo-founder