Pipeline

Two assets to the clinic, deliberately sequenced

Both compounds are ready to enter IND-enabling development. J-041 advances first because dermatomyositis qualifies for orphan drug designation. J-019 advances immediately behind it on the shared chemistry, formulation and manufacturing platform.

J-041
Dermatomyositis

J-019
Multiple sclerosis

Asset	Indication	Mechanism	Stage today	Next gate
J-041	Dermatomyositis — orphan	Full CB2 agonist, selective over CB1	In vivo efficacy complete; IND-enabling ready	Orphan designation filing, then IND
J-019	Multiple sclerosis	CB2 agonist with confirmed PPARγ activity	In vivo efficacy complete; enabling package staged	IND-enabling on the shared chemistry and CMC platform
Shared platform	Both programs	Common chemical scaffold	Analytical methods, formulation and CMC route established	Single chemistry, formulation and manufacturing base

J-041

Dermatomyositis · Lead asset

An oral CB2 full agonist for a rare autoimmune disease of skin and muscle with one approved therapy and no approved oral option.

Program detail

J-019

Multiple sclerosis · Second asset

An oral dual-mechanism candidate pairing CB2 agonism with confirmed PPARγ activity in a single molecule.

Program detail

Development plan

From IND-enabling work to J-041 in the clinic

Q4 2026

IND-enabling program begins: dose-range finding, GLP toxicology, oral pharmacokinetics.

Dec 2026 – Jan 2027

Orphan drug designation application filed for J-041 in dermatomyositis.

Q1 – Q3 2027

GMP manufacture and the full IND-enabling package for J-041. The shared synthetic route, analytical methods and formulation carry directly into J-019.

Q4 2027

IND filed for J-041.

Q1 – Q2 2028

IND clearance and Phase 1 initiation for J-041. J-019 IND-enabling completes.

IND-enabling program

Dose-range finding, GLP toxicology and oral pharmacokinetics, running 12 to 18 months. The synthetic route, analytical methods and formulation developed here transfer directly into J-019 rather than being rebuilt.

Phase 1

A single-ascending-dose and multiple-ascending-dose study in 40 to 80 healthy volunteers, planned for initiation in the first half of 2028, subject to IND clearance.

Development timelines are plans, not commitments. They depend on regulatory review, manufacturing readiness and the availability of program funding, and are subject to change.

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