Rare disease drugmaker · based in Redwood City, United States · founded 2010 · ticker RZLT · rezolutebio.com
Rezolute Inc works on Congenital Hyperinsulinism, one of the rare diseases we track. It has 2 active clinical trials, and 1 is looking for volunteers now.
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 11, 2025).
Rezolute Inc pipeline
Each row lists the diseases Rezolute Inc is studying at that stage, from the ones closest to approval down to the earliest work.
Phase 3
Large studies, usually the last step before a company asks the FDA for approval.
These are Rezolute Inc trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
1 trial looking for volunteers now
Looking for volunteersPhase 3Recently updatedNCT06881992
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
TestsErsodetug
For 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).
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.
Rezolute held a Type B meeting with the FDA on March 17, 2026, submitted the trial's continuous glucose monitor datasets in June 2026, and said on October 5, 2026 that the FDA recommended a pre-BLA meeting as a precursor to a Biologics License Application while explicitly not opining on approvability; no meeting date or filing has been disclosed.
A second Phase 3 trial, upLIFT, in tumor hyperinsulinism finished enrollment in October 2026 with results expected in mid-December 2026.
Where Rezolute Inc trials take place
The trials above run at 31 study sites in 15 countries. Tap a country to see its states, cities and hospitals.
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▼
Rare diseases Rezolute Inc works on
Each disease page lists every open trial, not only Rezolute Inc's, plus approved treatments.
Congenital hyperinsulinism (HI) is a rare genetic condition in which the insulin-making cells of the pancreas release too much insulin, driving blood sugar dangerously low in newborns and young...
How common: About 1 in 28,000 births in most countries, according to Congenital Hyperinsulinism International; NORD gives a range of 1 in 25,000 to 1 in 50,000
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Rezolute Inc's own site is rezolutebio.com, and our help paying for treatment page lists drugmaker programs and charity funds.
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 11, 2025). Rezolute held a Type B meeting with the FDA on March 17, 2026, submitted the trial's continuous glucose monitor datasets in June 2026, and said on October 5, 2026 that the FDA recommended a pre-BLA meeting as a precursor to a Biologics License Application while explicitly not opining on approvability; no meeting date or filing has been disclosed. A second Phase 3 trial, upLIFT, in tumor hyperinsulinism finished enrollment in October 2026 with results expected in mid-December 2026.
Rezolute Inc has active programs across 1 rare disease: Congenital Hyperinsulinism. Each disease page on Trial Friend shows the latest recruiting trials, FDA-approved treatments, and patient resources.
Yes. Rezolute Inc is a rare disease specialist headquartered in Redwood City, United States, founded in 2010. The company focuses primarily on developing treatments for rare and orphan diseases, with programs targeting Congenital Hyperinsulinism.
The clinical trials section on this page shows active and recruiting rare disease trials sponsored by Rezolute Inc, pulled live from ClinicalTrials.gov. Each trial card includes the study phase, recruitment status, conditions being studied, number of trial sites, and a direct link to the full study record. You can also explore individual disease pages to see trials from all sponsors for a specific condition.
To explore enrollment, find a recruiting trial in the clinical trials list on this page and click "View full study" to see the full ClinicalTrials.gov record, which includes eligibility criteria, study locations, and contact information for each trial site. Your doctor can also help determine if a specific trial is appropriate for your condition. Not all trials are open at every location, so check the site list for one near you.
None as of November 2026. Rezolute Inc has no FDA-approved drug yet; its programs are still in trials.
Most advanced: Ersodetug (pivotal trial missed its goal).
Where to watch: the FDA calendar lists any Rezolute Inc application once a decision date is public, and the trials list on this page shows what is recruiting now.
Rezolute Inc was founded in 2010 and is headquartered in Redwood City, United States. The company has been active for 16 years. It trades publicly under the ticker symbol RZLT. As a rare disease specialist, the company dedicates its resources to developing therapies for patients with rare and orphan conditions.