Rezolute Inc

Rezolute is a clinical-stage rare disease company focused on therapies for metabolic and orphan diseases affecting glucose metabolism. The company's lead asset ersodetug is a human monoclonal antibody targeting the insulin receptor. The Phase 3 sunRIZE trial in congenital hyperinsulinism did not meet its primary endpoint (reported December 2025), and Rezolute is exploring next steps with the FDA.

Type
Rare Disease Specialist
Ticker
RZLT
Headquarters
Redwood City, United States
Founded
2010
2
Active Rare Disease Trials
16
Years Active

Focus areas at Rezolute Inc

The clinical trials section below shows all active and recruiting studies sponsored by Rezolute Inc, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Rezolute Inc is headquartered in Redwood City, United States, founded in 2010, publicly traded under the ticker symbol RZLT. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Rezolute Inc Drug Pipeline

Rezolute Inc has 2 active clinical trials across 1 development stage, with 2 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Rezolute Inc's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Rezolute Inc's pipeline
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2
Phase 32 trials
Tumor Hyperinsulinism (Tumor HI)
Recruiting
Congenital Hyperinsulinism
Recruiting

Rezolute Inc Clinical Trials (2)

Active and recruiting clinical trials sponsored by Rezolute Inc, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Rezolute Inc's trials
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RECRUITINGPHASE3Recently updatedNCT06881992

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Intervention: Ersodetug

Tumor Hyperinsulinism (Tumor HI)

The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).

Ages 18 Years+13 locations
View full study
ACTIVE NOT RECRUITINGPHASE3No updates in a whileNCT06208215

RZ358 Treatment for Congenital Hyperinsulinism

Intervention: RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC, RZ358 (5-10 mg/kg) + SOC

Congenital Hyperinsulinism

The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

Ages 3 Months - 45 Years18 locations
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FDA-Approved Drugs

No FDA-approved drugs found for this company at this time.

Rezolute Inc Trial Locations

Rezolute Inc clinical trials are running at 31 sites in 15 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
10▼
United Kingdom
4▼
France
3▼
Germany
2▼
Spain
2▼
Netherlands
1▼
Switzerland
1▼
Bulgaria
1▼
Denmark
1▼
Georgia
1▼
Greece
1▼
Oman
1▼

Frequently Asked Questions About Rezolute Inc

Common questions about Rezolute Inc's rare disease programs, clinical trials, and treatments.