Rejuvenate Biomed NV

Rejuvenate Biomed is a clinical-stage biotech company that uses AI to develop combination therapies of existing approved drugs to impact the onset of multiple diseases of aging. It has a pipeline of assets for COPD-related sarcopenia, muscle weakness, and other age-related conditions.

Based on their website, it appears that Rejuvenate uses its CombinAge™ AI discovery engine to identify combinations of already-approved drugs that simultaneously impact multiple aging pathways, and then screens them in vivo with their C. elegans CelegAge™ system. Rejuvenate proposes that their use of established drugs with known human safety profiles will enable them to reduce development risks and time. Yet despite their use of existing drugs, they state that they “secure strong patent protection, both composition and medical applications & formulation.”

RJx-01
Rejuvenate’s lead candidate, RJx-01, is a proprietary combination of the approved Alzheimer’s drug galantamine and the diabetes drug metformin, under development for the treatment of sarcopenia (the age-related loss of muscle mass or strength that occurs even in people engaged in resistance exercise).

In August 2023, Rejuvenate-affiliated scientists reported that treating C. elegans worms with the RJx-01 combination increased lifespan more than either drug alone, and also improved locomotion and pharyngeal pumping in adult animals, with results being inconsistently superior to each drug alone. RJx-01 also improved muscle fiber organization, although results for monotherapy with constituent drugs were not reported. Importantly, animals began treatment at the late L4 larval stage and were tested at adult day seven (C. elegans lifespan is 2-3 weeks), so the translatability of these results to treatment beginning in middle age or early seniority is uncertain.

In the same report, RJx-01 ameliorated the aging-like deficits in running time, muscle weight and cross-sectional area, denervated muscle fibers, muscular strength, and systemic inflammation in inducible muscle-specific Opa1-knockout mice, which develop sarcopenia-like deficits in what is normally young adulthood. These improvements were consistently superior to those of the constituent drugs alone.

Still in this first report, the investigators treated physiologically-aged wild-type mice with RJx-01 for eighteen weeks. The treatment did not affect food intake, body weight, muscle mass, mean fiber size, fiber size distribution, or fiber type, but did increase running time, grip strength, sarcomere structure, and muscle mitochondrial morphology, while decreasing muscle fiber denervation by 15%.

In October 2023, Rejuvenate announced positive results in a Phase Ib trial of RJx-01 in 42 male subjects aged 65 to 75 with muscle atrophy induced by spending two weeks with one leg immobilized in a cast, followed by observation for an additional four weeks after removing the cast, and then a muscular strength rehabilitation program. The drug was said to be generally safe and well-tolerated with no reported treatment-related severe adverse events. Additionally, the company stated that the drug had exhibited excellent bioavailability.

In February 2024, Rejuvenate announced the functional outcome results from the Phase Ib trial. Compared to placebo-treated subjects, the company stated that those who received RJx-01 exhibited improvements in muscle strength recovery as assessed via isometric dynamometry (typically, this refers to assessing grip strength via a handheld device); leg acceleration, assessed through isokinetic dynamometry; and fatigue resistance, “assessed by monitoring muscle parameters during a series of leg exercises.” At the time, the company announced that they were “actively exploring partnership opportunities to investigate RJx-01 in combination with GLP-1 drugs.”

In October 2024, Rejuvenate announced that it had entered into an agreement with the University of Leicester, the National Institute for Health and Care Research (NIHR), and the Leicester Biomedical Research Centre (BRC) to perform a Phase II trial of RJx-01 in patients with chronic obstructive pulmonary disease (COPD)-related sarcopenia. The trial is enabled by multimillion-dollar funding from the Dynamic Resilience program, which is co-funded by Wellcome Leap and Temasek Trust. The trial will primarily assess RJx-01’s safety and tolerability in 130 older persons following hospitalization with a severe acute exacerbation of COPD, and will secondarily evaluate its effects on physical function, muscular strength, and fatiguability.

In May 2025, Rejuvenate announced that it had dosed the first patient in the Phase II trial.

Rejuvenate’s platform diagram indicates that it is in Phase II for a second, unnamed indication; however, the company has not reported any other trials. Speculatively, this may relate to a February 2024 announcement that they were “actively exploring partnership opportunities to investigate RJx-01 in combination with GLP-1 drugs,” highlighting their use in Type II diabetes.

Other Candidates
Rejuvenate’s platform diagram indicates that it has four additional candidates under development: RJx-02 in preclinical development, and RJx-03 through RJx-05 in discovery.