An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
FDA Approves Novo Nordisk’s Awiqli®
On March 26, Novo Nordisk announced that the US Food and Drug Administration (FDA) approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes.
This new approval offers the only once‑weekly basal insulin option, recognizing the importance of personalized care and the need for treatments that fit different patient routines and preferences for adults living with type 2 diabetes
“Awiqli® is an important new option that meets a real need as the first FDA-approved, once-weekly basal insulin for adult patients with type 2 diabetes. It’s helping to reframe what basal insulin care can look like,” said Anna Windle, PhD, Group Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. “Awiqli® may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week. It is an important advancement for adults with type 2 diabetes who may benefit from an alternative treatment option.”
This approval is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® injection which comprises four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists.
The clinical program evaluated once-weekly Awiqli® vs. daily basal insulin and demonstrated efficacy in the primary endpoint of reduction of A1C across the ONWARDS pivotal clinical trial program for adults with type 2 diabetes. Across these ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class.3-6 Common adverse events include hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
Diadia Health Exits Beta as First AI Causal Reasoning Platform for Precision Medicine in Complex Endocrine and Chronic Disease Cases
On March 19, Diadia Health officially launched its AI causal reasoning platform nationwide following successful beta validation across 12+ clinical sites and thousands of patient cases. The platform analyzes genetic variants and lab results to help clinicians identify potential root causes in complex chronic disease cases and generate personalized treatment recommendations with 60% less trial-and-error than standard protocols. The platform focuses particularly on complex endocrine, metabolic, and hormonal conditions, where under-researched pathways create significant diagnostic gaps. Diadia brings precision medicine insights to cases where standard lab tests return normal results despite persistent symptoms.
Diadia’s platform analyzes patterns across nearly one million genetic variants, over 100 metabolic pathways, and hundreds of biomarkers simultaneously to generate prioritized treatment protocols. Functioning as a vendor-agnostic intelligence layer on top of existing lab data sources, Diadia augments rather than replaces clinician judgment, with 98% of AI-generated reports requiring zero revision before clinical use.
“Precision medicine will be AI-first because of large data volumes. There’s no way a single physician could streamline all that information,” said Dr. Anil Bajnath, MD, founder of the American Board of Precision Medicine. “I already know, after going through iterations of it, that Diadia is going to be one of the best technologies I’ve seen to help bring precision medicine to the forefront of healthcare.”
Diadia draws on a growing database of 310,000+ peer-reviewed research papers and was developed by AI veterans and precision medicine specialists from Stanford, Berkeley, Penn Medicine, Uber, and IBM. Unlike consumer wellness apps or LLM-based tools that can produce unreliable outputs, Diadia utilizes genomic data and predictive biomarker patterns to determine not only genetic predisposition but also whether specific genes are actively expressed. The platform maps biological relationships among genetics, lab results, and patient history to generate transparent reports that show clinicians the exact medical logic and nearly 100 peer-reviewed research citations behind every rationale and recommendation.
“A recent study supported by Harvard Medical School, Johns Hopkins, and other expert institutions noted that 91.8% of clinicians have ‘encountered medical hallucinations.’ If AI hallucinates upstream, you get garbage downstream,” Bajnath said. “What’s exciting about Diadia is they’ve accounted for that hallucination potential and eliminated those choke points. This is a non-hallucinating, evidence-driven AI copilot.”
After leading AI at Reddit and prototyping technology for Google, Dr. Ikonomovska founded Diadia to address blanket treatment protocols and bring interpretability to the complex interconnections between genetic expression, biomarkers, and clinical presentation in chronic disease. Born from her own experience navigating unexplained symptoms with normal lab results, Diadia’s research-backed platform focuses specifically on cases where standard diagnostic approaches fail to identify root causes.
Backed by Salesforce Ventures, Sound Ventures, Tribe Capital, and others, Diadia validated the platform across dozens of clinical sites during beta testing, and is now scaling to meet demand for AI diagnostic support tools that provide transparent, evidence-based clinical reasoning.
Diadia is now available to healthcare providers nationwide. Clinicians interested in integrating the platform can learn more at: diadiahealth.com.
Rezolute Provides Update on its Congenital Hyperinsulinism Program Following FDA Meeting
On March 24, Rezolute, Inc., announced outcomes from an in-person Type B meeting with the U.S. Food and Drug Administration (FDA) held on March 17, 2026, related to sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital hyperinsulinism (HI). Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI).
In December 2025, the Company reported that sunRIZE demonstrated reductions from baseline in hypoglycemia events, but the study did not meet its primary endpoint because the reductions were not statistically significant compared to placebo, which the Company believes was a result of a pronounced study effect.
Although consistent and clinically significant improvements in time in hypoglycemia by continuous glucose monitoring (CGM) were observed compared to placebo over the course of the entire pivotal treatment period, nominal statistical significance was not achieved in this key secondary endpoint at the pre-specified Week 24 end-of-treatment period.
During the meeting with FDA, the company presented summary results from sunRIZE including: (i) information to support the Company’s belief that the primary endpoint was confounded as a result of behavioral factors; (ii) evidence of pharmacologic activity, as target therapeutic drug concentrations were achieved in both treatment groups with highly sensitive biomarker responses of decreased insulin cell signaling; (iii) consistent improvements compared to placebo in time in hypoglycemia and a variety of other CGM-based glycemic endpoints; and (iv) preliminary favorable observations from the ongoing open-label extension portion of the study (OLE), which indicate continued improvement in glycemic parameters in the ersodetug treatment arms and placebo roll-over, concurrent with a notable reduction of other background standard-of-care therapies.
The FDA acknowledged the challenges posed by the potential impact of varied behavioral factors on clinical trials in this heterogeneous patient population, including the associated limitations of self-monitored blood glucose (SMBG) based metrics in measuring hypoglycemia in congenital HI.
Rezolute says it believes that the unblinded nature of self-monitored glucose necessary for patient standard of care, together with perceptions of treatment assignment, may have led to divergent behaviors between treatment groups during the study, which may have impacted the measurement of hypoglycemia by SMBG. While acknowledging these challenges, the agency reiterated the expectation for adequate and well-controlled studies and outcomes as the standard for evaluating substantial evidence of efficacy criteria as the basis for approving new therapies.
The agency and the company then discussed summary outcomes from various CGM-based glycemic endpoints and preliminary observations from the OLE. These and other outcomes from the pivotal portion of the sunRIZE trial will be shared by oral presentation at an upcoming scientific conference. As a next step for the program, FDA encouraged the Company to submit study reports and analysis datasets for the agency’s independent evaluation. Following that review, the Company believes that a determination may be made whether there is sufficient evidence to support the submission of a marketing application for sunRIZE or if additional information is required. The Company expects to have an update on the program in the second half of 2026.
“We are extremely encouraged by the outcome of our meeting with FDA including the fact that, while acknowledging their feedback was preliminary, the agency did not dismiss sunRIZE outright on the basis of not meeting its primary endpoint,” said Nevan Charles Elam, CEO and Founder of Rezolute. “FDA was engaged with the content we presented, asked astute questions necessary to fully understand the results, and expressed a desire to conduct a thorough review that would assist in decision making regarding advancement of the program.”
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