Therapeutics

From mechanism to medicine

Senovance's systemic lead program is directed at two lead indications, sarcopenia and androgenetic alopecia, from a single chemistry and a single mechanism. First-in-human dosing was completed in 2026.

8
Indications in development

Skin, neurodegeneration, and age-related fibrotic and metabolic disease, addressed from one chemistry and one mechanism.

2
Human IITs completed

Investigator-initiated: androgenetic alopecia has read out, and ALS is complete.

2027
IND submission

Two lead indications: sarcopenia and androgenetic alopecia.

One program, built for the clinic

Lead program — 01

Completed

Pharmacodynamic, pharmacokinetic, and toxicology studies in aged rats are complete. Complement-activation and PBMC safety assays were both negative, the drug-substance process has been finalized, and an exploratory human trial in ALS has been completed.

Ongoing

A dose-ranging and pharmacokinetic study in non-human primates is underway: subcutaneous administration, three dose levels, and serial muscle biopsies at four time points, to inform dose interval and exposure.

Ongoing
NHP pharmacokinetic readout

Muscle half-life and duration of target engagement following subcutaneous dosing, the preclinical basis for dose-interval design.

Late 2026
First-in-human dosing

The first clinical-stage readout for the systemic lead program, following ethics review at the trial center.

2027
IND filing

Entry into the registered clinical pathway for the two lead indications.

Built for a human dosing regimen

Developability — 02

A single-dose pharmacokinetic program in aged animals compared intravenous and subcutaneous administration directly, with serial sampling of plasma and five tissues at multiple time points. Each conclusion rests on direct observation rather than on extrapolation from a fitted half-life, and together they converge on a long-interval, self-administered regimen.

Sustained skeletal-muscle exposure after a single doseLONG INTERVAL
Subcutaneous dosing preserves muscle exposure while substantially lowering hepatic exposureSELF-INJECTABLE
Tissue retention on the order of a monthly dosing intervalQ4W-CLASS POTENTIAL
Two-part lyophilized formulation, stable through ambient distributionAMBIENT-STABLE

In a chronic disease of old age, the route and interval of administration are not an engineering detail; they determine whether long-term efficacy is realized at all.

Rat pharmacokinetics · Single dose · IV vs SC · Plasma and five tissues

Sarcopenia: an indication with no approved therapy

Lead Indication I — 03

The indication

Sarcopenia, the progressive loss of skeletal muscle mass and function, received its own disease code in 2016. No major regulator has approved a therapy for it, and first-line guidance remains exercise and nutrition. The global patient population numbers in the tens of millions and is growing on demographics alone.

Seven prior development programs added muscle mass without restoring function, and every one of them failed on its functional endpoint. The rise of GLP-1 therapies has widened the gap: between a quarter and forty percent of the weight lost on these therapies is lean mass, and since January 2025 the FDA has required weight-loss trials to follow body composition, to confirm that the loss is fat rather than muscle or bone.

The program

Senovance's program acts upstream, reversing the senescence of the tissue's own regenerative cells. Of the three upstream routes, this is the only program at IND-enabling stage: the leading company on the clearance route has been liquidated, and the suppression route has not left preclinical research.

An investigator-initiated trial in sarcopenia is in ethics review. Separately, first-in-human dosing of the systemic lead program was completed in 2026.

Androgenetic alopecia: the first human readout

Lead Indication II — 04

The indication

Androgenetic alopecia is the most common form of hair loss, affecting a majority of men and half of women by their seventies. The global treatment market, projected to approach five billion dollars by 2030, still rests on two drugs approved decades ago: a daily topical agent that stimulates growth without addressing the cause, and an oral anti-androgen associated with sexual dysfunction.

Transplantation redistributes follicles but does not alter progression. The unmet need is a cause-directed, long-acting, non-hormonal therapy.

The program

Androgenetic alopecia is driven by the premature senescence of dermal papilla cells in the balding region, which places it directly on the platform's mechanism. An investigator-initiated, within-subject-controlled human trial in severe, rapidly progressing disease has read out positive on every quantitative endpoint, in every subject, and under every analytical convention, with separate animal measurements of dermal delivery and target inhibition corroborating the mechanism at tissue level.

A blinded confirmatory study with intensified dosing and extended follow-up has been designed as the next step.

ALS: safety as the primary objective, with signals beyond it

Exploratory IIT — 05

The indication

Amyotrophic lateral sclerosis is relentlessly progressive: median survival from diagnosis is little more than a year, and in the natural history of the disease fewer than one percent of patients show a sustained functional improvement. Three decades of research and more than a hundred trials have produced four FDA approvals, of which three remain on the market and one has been withdrawn; the most recent reaches only the small genetic fraction of patients.

The unmet need spans every genotype.

The program

An investigator-initiated trial enrolled end-stage patients who had been diagnosed more than four years earlier and fell outside the enrollment window of every pivotal ALS trial conducted to date. They were dosed weekly by subcutaneous injection over twelve weeks, at conservative doses, with safety as the primary objective.

The study was well tolerated, with no serious adverse events reported. Most patients showed a clear response: a clinically validated neurological-injury biomarker fell markedly, accompanied by functional recovery across bulbar and spinal domains, and responders asked to continue treatment. The biomarker class at the core of this readout was accepted by the FDA in a 2023 accelerated approval as a surrogate endpoint reasonably likely to predict clinical benefit.

The expanded portfolio

Portfolio — 06
01

Progeria

Hutchinson-Gilford progeria syndrome is an ultra-rare, fatal segmental aging disease and the most direct human presentation of accelerated senescence, occurring in children. The first and only approved therapy, cleared in 2020, reduces mortality risk but does not halt the disease. For a reversal platform, progeria represents the mechanism in its purest form.

IIT approved
02

Alzheimer's Disease

Alzheimer's disease is the most common cause of dementia, affects tens of millions of people worldwide, and sits in a market projected to more than double within the decade. The new anti-amyloid antibodies slow decline without arresting it, carry an infusion burden and a risk of brain edema, and remain out of reach for most patients. A senescence-directed mechanism is orthogonal to amyloid and, by hypothesis, additive to it.

IIT ethics review in progress · two academic clinical centers
03

Multiple System Atrophy

Multiple system atrophy is a rare, rapidly progressive disorder that combines parkinsonian, cerebellar, and autonomic failure, with survival measured in years and a prevalence of a few per hundred thousand. No approved disease-modifying therapy exists, and treatment is symptomatic. Senescent glia are increasingly implicated in the spread of synuclein.

IIT ethics review in progress
04

Liver Fibrosis

Chronic liver injury culminates in fibrosis, a form of scarring that no approved therapy reverses. Senescent cells are active drivers of the fibrotic program in the liver.

Preclinical candidate
05

Renal Fibrosis

Renal fibrosis is the final common pathway of chronic kidney disease, progressing silently toward renal failure and dialysis. As in the liver, no anti-fibrotic therapy has been approved.

Preclinical candidate
06

NASH / NAFLD

Metabolic liver disease affects approximately one in five adults worldwide. The first dedicated approval was granted in 2024 and a GLP-1 therapy followed in 2025, and the market is projected to increase severalfold by the 2030s. The platform's readouts in aged primates, in which transaminases declined while those of controls rose, bear directly on this indication.

Preclinical candidate

Full indication matrix

Matrix — 07
SarcopeniaIIT ethics review in progress
Androgenetic alopeciaHuman IIT read out
ProgeriaIIT approved
Alzheimer's diseaseIIT ethics review in progress
Multiple system atrophyIIT ethics review in progress
Amyotrophic lateral sclerosisHuman IIT completed
Liver fibrosisPreclinical candidate
Renal fibrosisPreclinical candidate
NASH / NAFLDPreclinical candidate
Skin aging — consumer healthcareRegistration completed