Juvena Therapeutics Contact

Pipeline

Every program began as secreted proteins.

Every asset in Juvena's development pipeline was discovered and developed by its proprietary JuvNET platform, a "pipeline in a product." The lead, JUV-161, is a first-in-class muscle-regenerating biologic now in a Phase 1/Phase 2 study.

Program
JUV-161Sarcopenia, Atrophy
Phase 1/Phase 2, enrolling
JUV-161: Muscular Dystrophy: DM1 / BMD / FSHD / OPMD
Phase 1
JUV-112Metabolic, Body Composition
Preclinical
Fibroinflammatory
Discovery
Partnering
Lilly CollaborationMuscle health + body composition
Discovery

Pipeline as of September 2026, as shown in Juvena's corporate overview. JUV-161 holds FDA orphan drug designation for myotonic dystrophy type 1. All programs are investigational; safety and effectiveness have not been established, and no product candidate has been approved by the FDA or any other regulatory authority.

Lead program

JUV-161

A first-in-class fusion protein designed to restore the signals that drive muscle formation and function.

Mechanism

JUV-161 is an engineered protein derived from insulin-like growth factor 2 (IGF2), a naturally occurring protein secreted by human stem cells that helps coordinate muscle formation, function, and metabolism. Designed for subcutaneous administration, JUV-161 aims to restore AKT signaling, a key pathway regulating cell survival, growth, and metabolism that is impaired with aging and in muscle-wasting conditions. In animal disease models, JUV-161 promoted the formation of new muscle fibers, reduced atrophy, and improved strength, endurance, and muscle metabolism.

Indications

Myotonic dystrophy type 1 (DM1) is the first target indication; JUV-161 holds FDA orphan drug designation for DM1 (January 2024). Juvena is also evaluating JUV-161 in muscle atrophy, with additional muscular dystrophies (Becker, facioscapulohumeral and oculopharyngeal) and sarcopenia as potential applications.

Clinical status

January 2024FDA orphan drug designation for DM1.
May 2025First-in-human Phase 1 study initiated: a randomized, double-blind, placebo-controlled single-ascending-dose study of a single subcutaneous dose in healthy adult volunteers (Australia; NCT06918925), assessing safety, tolerability, pharmacokinetics and pharmacodynamics.
August 2026Phase 1 (single and multiple ascending doses) completed.
2026Phase 1/Phase 2 study of muscle atrophy (unilateral lower-limb immobilization) now enrolling.

JUV-161 is an investigational medicine. No efficacy data in patients have been disclosed; its safety and effectiveness have not been established.

Clinical studies for patients & families

Discovery

Fibroinflammatory and musculoskeletal disease

JuvNET has identified dozens of tissue-restorative secreted-protein hits beyond muscle, spanning pulmonary fibrosis, hepatic fibrosis and osteoarthritis. Juvena is advancing discovery programs in fibroinflammatory and musculoskeletal disease where a degenerative or inflammatory cause, a biologic-addressable tissue target and a major unmet need come together.

Juvena has also described JUV-112, a preclinical secreted-protein candidate for adipose-related metabolic diseases. It is designed to promote fat breakdown while preserving muscle, without suppressing appetite, through a mechanism distinct from incretin-based therapies. The program demonstrates the platform's broader reach into metabolic biology, capabilities that now support Juvena's collaboration with Lilly.

How JuvNET works

Partnering

Lilly collaboration in muscle and metabolic health

In June 2025 Juvena and Eli Lilly and Company entered a global licensing and multi-target research collaboration to discover, develop and commercialize candidates that improve muscle health and body composition, with a focus on chronic conditions such as obesity and frailty.

Juvena applies JuvNET to its proprietary library of human stem-cell-secreted proteins to identify muscle-targeting candidates; Lilly receives an exclusive license to selected leads and is responsible for their further research, development and commercialization. Juvena received an upfront payment and an equity investment, and is eligible for potential development and commercialization milestones. Lilly also participated in Juvena's $33.5M Series B in January 2026.