This section highlights FDA-related milestones and regulatory updates for drugs developed by Rezolute (RZLT).
Over the past two years, Rezolute has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ersodetug and RZ358. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ersodetug - FDA Regulatory Timeline and Events
Ersodetug is a drug developed by Rezolute for the following indication: For Hypoglycemia Due to Congenital Hyperinsulinism.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ersodetug
- Announced Date:
- July 9, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc announced that the abstract titled "Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress" has been selected for a late-breaking presentation at ENDO 2025 taking place July 12-15, 2025 in San Francisco, CA, USA.
AI Summary
Rezolute, Inc., a late-stage rare disease company, announced that its abstract titled "Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress" has been selected for a late-breaking presentation at ENDO 2025. The presentation is scheduled for July 14, 2025, in San Francisco, CA, and will be delivered as a poster during the Pediatric and Adolescent Endocrinology session.
The study focuses on evaluating ersodetug, a promising new therapy for treating hypoglycemia caused by congenital hyperinsulinism. It will share key early data, including patient demographics and baseline characteristics, which are crucial for understanding how this Phase 3 trial compares with earlier research. With enrollment now complete and topline data expected in December, the study may help offer a much-needed treatment option for patients with limited alternatives.
Read Announcement- Drug:
- Ersodetug
- Announced Date:
- May 28, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced that enrollment is complete in the sunRIZE study, a global, Phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug for the treatment of hypoglycemia in patients with congenital HI.
AI Summary
Rezolute, Inc. recently announced that enrollment is now complete for its sunRIZE study, a global Phase 3 clinical trial focused on evaluating the efficacy and safety of ersodetug for patients with congenital hyperinsulinism (HI). The study is a multicenter, double-blind, randomized, placebo-controlled trial designed to assess how well ersodetug treats hypoglycemia in these patients. A total of 62 participants were enrolled, including approximately 15 percent from U.S. sites, surpassing the initial enrollment target. The trial compares two dosing levels of ersodetug with a placebo, each administered alongside the current standard of care. Key measures include the change from baseline in the average number of hypoglycemic events per week and the average percent time in hypoglycemia over a six-month treatment period. Rezolute views this milestone as a promising step toward potentially bringing a new treatment option to patients and expects topline data in December 2025.
Read Announcement- Drug:
- Ersodetug
- Announced Date:
- May 5, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI.
AI Summary
Rezolute, Inc. announced that the FDA has granted Breakthrough Therapy Designation (BTD) for its investigational therapy, ersodetug, to treat hypoglycemia caused by tumor hyperinsulinism (HI). The designation was based on solid clinical trial data and real-world success from the Company’s Expanded Access Program. BTD is designed to speed up the development and regulatory review process for treatments of serious conditions, highlighting the potential of ersodetug to offer significant benefits over existing options.
Rezolute believes that the drug’s unique mechanism can effectively manage persistent hypoglycemia in tumor HI patients, where current therapies often fall short. This achievement highlights the urgent need for new treatments in oncology. The Company also plans to initiate a registrational study mid-2025, with topline results expected in the second half of 2026.
Read Announcement - Drug:
- Ersodetug
- Announced Date:
- April 23, 2025
- Estimated Event Date Range:
- December 1, 2025 - December 31, 2025
- Target Action Date:
- December 01, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced that topline data anticipated in December 2025
AI Summary
Rezolute, Inc. announced positive news about their Phase 3 sunRIZE study for congenital hyperinsulinism. An independent committee recommended continuing the study without increasing the sample size. The enrollment is on track and is expected to finish by May 2025, with U.S. sites now active and enrolling patients. Most notably, Rezolute anticipates that topline data will be available in December 2025. This milestone is important as it will provide critical information on the safety and efficacy of their antibody treatment, ersodetug. The progress of the study underlines the company’s commitment to advancing a treatment option that can potentially address a serious, unmet need in patients with congenital hyperinsulinism. The topline data release is eagerly awaited as it will help determine the future potential of this promising therapy.
Read Announcement- Drug:
- Ersodetug
- Announced Date:
- April 23, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced that Enrollment on track and expected to be completed in May 2025
AI Summary
Rezolute, Inc. announced promising news for its Phase 3 sunRIZE clinical trial. The company's Independent Data Monitoring Committee recently recommended that the trial continue as planned without increasing the sample size. U.S. clinical sites are now active and enrolling patients, contributing to a global effort aimed at testing the safety and effectiveness of ersodetug for patients with congenital hyperinsulinism.
The company confirmed that enrollment is on track and is expected to be completed in May 2025. Rezolute also noted that topline data from the trial are anticipated in December 2025. This strong enrollment progress marks a key milestone in the study, which is designed to evaluate a treatment option that may help improve hypoglycemia management in patients with this rare condition.
Read Announcement- Drug:
- Ersodetug
- Announced Date:
- April 23, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced the DMC's recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital HI, without an increase in the study sample size.
AI Summary
Rezolute, Inc. announced that the Independent Data Monitoring Committee (DMC) has advised continuing the Phase 3 sunRIZE study as planned without increasing the study sample size for patients with congenital hyperinsulinism (HI). The recommendation followed a pre-specified analysis of the primary endpoint, which focuses on hypoglycemia events, and was conducted after about half of the enrolled patients completed their primary assessments.
This positive decision supports Rezolute's initial assumptions for the study’s design, aligning with previous data from the Phase 2 RIZE study and real-world observations from their Expanded Access Program. U.S. sites are now enrolling patients, with overall study enrollment expected to finish in May 2025 and topline results anticipated in December 2025. The study examines the potential of ersodetug to become a best-in-class treatment option for individuals with congenital HI.
Read Announcement- Drug:
- Ersodetug
- Announced Date:
- February 4, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced that sunRIZE enrollment completion expected in Q2 2025
AI Summary
Rezolute, Inc. announced an important update on its Phase 3 sunRIZE study for treating hypoglycemia due to congenital hyperinsulinism. After a Data Monitoring Committee review, the open-label arm involving infants under one year of age showed that the tested doses reached safe and expected drug levels. Based on these findings, the DMC approved continuing by enrolling more infants in the double-blind portion of the trial. The company stated that, barring any unexpected results from the next interim analysis, enrollment for the study is expected to be completed by the second quarter of 2025. This timeline is key as it paves the way for obtaining more comprehensive data on the drug’s safety and proper dosing in very young patients, which could ultimately bring a transformative therapy closer to those affected by this rare condition.
Read Announcement- Drug:
- Ersodetug
- Announced Date:
- February 4, 2025
- Indication:
- For Hypoglycemia Due to Congenital Hyperinsulinism
Announcement
Rezolute, Inc. announced outcomes from an independent Data Monitoring Committee (DMC) review of the open label arm (OLA) portion of the sunRIZE Phase 3 study of ersodetug for the treatment of hypoglycemia due to congenital hyperinsulinism (HI) and provided additional study updates including guidance on its upcoming interim analysis (IA) by the DMC.
AI Summary
Rezolute, Inc. has announced positive outcomes from an independent Data Monitoring Committee (DMC) review of the open label arm in its sunRIZE Phase 3 study. The review focused on infant participants (ages 3 months to 1 year) being treated with ersodetug for hypoglycemia due to congenital hyperinsulinism. The DMC confirmed that target drug concentrations were safely reached at the tested doses, validating the safety and pharmacokinetics of the chosen dosing regimen of 5 and 10 mg/kg. Based on these findings, the DMC has approved the enrollment of infants into the double-blind, placebo-controlled part of the study.
The company also provided further study updates, noting that an upcoming interim analysis will review the adequacy of the sample size for the study’s primary endpoint. This analysis may recommend adjustments to the number of study participants if needed, ensuring robust and reliable final results.
Read Announcement
RZ358 - FDA Regulatory Timeline and Events
RZ358 is a drug developed by Rezolute for the following indication: Post-gastric bypass hypoglycemia (PGBH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RZ358
- Announced Date:
- January 7, 2025
- Indication:
- Post-gastric bypass hypoglycemia (PGBH)
Announcement
Rezolute, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ersodetug (RZ358) for the treatment of hypoglycemia due to congenital HI.
AI Summary
Rezolute, Inc. recently announced that the FDA has granted its drug ersodetug (RZ358) Breakthrough Therapy Designation for treating hypoglycemia caused by congenital hyperinsulinism (HI). This special designation helps speed up the development and review of promising treatments for serious, life-threatening conditions. The decision was largely based on findings from the Phase 2b RIZE study, where patients showed significant improvements—reducing hypoglycemia by 75% or more without a rise in clinically significant hyperglycemia.
The Breakthrough Therapy Designation highlights the potential of ersodetug to offer a more effective treatment option for congenital HI. Rezolute sees this milestone as key progress in addressing the unmet needs of children who suffer from this condition. The company is focused on completing recruitment for its ongoing sunRIZE study, with topline results expected later this year, marking an important step forward in its clinical development efforts.
Read Announcement- Drug:
- RZ358
- Announced Date:
- December 3, 2024
- Indication:
- Post-gastric bypass hypoglycemia (PGBH)
Announcement
Rezolute, Inc announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ersodetug for the treatment of hypoglycemia due to tumor HI.
AI Summary
Rezolute, Inc. announced that the FDA has granted Orphan Drug Designation (ODD) to its antibody therapy, ersodetug, for treating hypoglycemia caused by tumor hyperinsulinism (HI). This designation acknowledges the significant unmet need faced by patients with tumor-induced HI, a condition linked to dangerous low blood sugar levels. The FDA’s decision supports the idea that ersodetug could offer substantial benefits by targeting the over-activation of insulin receptors, a key factor in hypoglycemia related to both islet cell and non-islet cell tumors. With this designation, the therapy may receive advantages such as seven years of market exclusivity and expedited development pathways. Rezolute is encouraged by the decision, as it validates their approach and could help speed the availability of a much-needed treatment for patients battling this rare and challenging condition.
Read Announcement- Drug:
- RZ358
- Announced Date:
- September 9, 2024
- Indication:
- Post-gastric bypass hypoglycemia (PGBH)
Announcement
Rezolute, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital HI.
AI Summary
Rezolute, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on its experimental drug RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital hyperinsulinism (HI). This decision allows the company to move forward with its global Phase 3 sunRIZE study, which evaluates the safety and effectiveness of the drug. The FDA’s decision was based on a determination that the liver toxicity observed in animal studies is likely strain-specific and not relevant to humans.
With the hold lifted, Rezolute will begin study start-up activities in the U.S., aiming to enroll participants, including children as young as three months, as early as 2025. This clearance marks a significant step in the clinical development of ersodetug as a promising treatment option for congenital HI.
Read Announcement- Drug:
- RZ358
- Announced Date:
- August 5, 2024
- Indication:
- Post-gastric bypass hypoglycemia (PGBH)
Announcement
Rezolute, Inc. announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI).
AI Summary
Rezolute, Inc. recently received FDA clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug), which is designed to treat hypoglycemia in patients with tumor hyperinsulinism (HI). This clearance allows the company to initiate a Phase 3 clinical study in the United States, with patient enrollment planned to begin in the first half of 2025. The study will evaluate the safety and efficacy of RZ358 compared to a placebo in individuals experiencing poorly controlled hypoglycemia as a result of tumor HI, an area of significant unmet medical need.
The FDA’s decision reflects confidence in the potential of ersodetug to improve patient outcomes. In earlier real-world use under the Expanded Access Program, patients with tumor HI experienced notable benefits, reinforcing the promise of RZ358 as a universal treatment for hypoglycemia associated with HI.
Read Announcement
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