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The US FDA approved Awiqli (insulin icodec-abae; 700 units/mL) to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet & exercise, with Novo planning a US launch in the FlexTouch device in H2’26
Approval was based on the P-IIIa (ONWARDS) program assessing Awiqli (QW) vs basal insulin (QD) in…
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The P-II trial assessed UBT251 (2, 4 & 6 mg, QW, SC) vs PBO & semaglutide (1mg) in 211 Chinese T2D pts, which showed HbA1c reduction of 2.16% vs 1.77% (semaglutide) & 0.66% (PBO) at 24wks. from a baseline of 8.12%
Trial also showed weight loss of up to 9.8% vs 4.8% (semaglutide) &…
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Trial assessed retatrutide vs PBO, alongside lifestyle intervention in T2D adults (n=537) inadequately controlled with diet & exercise alone & mean disease duration of 2.5yrs.; pts started at 2mg QW, with dose escalation at Q4W till assigned doses of 4mg, 9mg, or 12mg are reached
Trial met its 1EP, showing superior A1C reduction at…
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Insulet has presented data from the EVOLUTION 2C feasibility study (n=24, 16-70yrs.) assessing its fully closed-loop (FCL) automated insulin delivery system (AID) for T2D at the ATTD’26
Trial showed that the final FCL algorithm increased TIR to an average of 68% with no boluses, a 24% improvement vs standard injection therapy, while TBR remained…
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Sciwind Biosciences has granted Pfizer China exclusive commercialization rights to Ecnoglutide injection in Mainland China
As per the deal, Sciwind will retain the MA & will be responsible for R&D, registration, manufacturing, & supply, plus is eligible to receive ~$495M in upfront, regulatory, & sales milestones
Independently developed by Sciwind, Ecnoglutide is a cAMP-biased…
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MannKind has enrolled the first patient in the P-II (INHALE-1st) trial assessing initiation of Afrezza(insulin human) Inhalation Powder in pediatric pts shortly after their type 1 diabetes diagnosis
Trial will evaluate Afrezza over 13wks., followed by an optional extension phase for pts continuing to use Afrezza with basal insulin up to 26wks., assessing the proportion…
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The P-III trial evaluated CagriSema (SC; QW), a fixed-dose combination of cagrilintide & semaglutide, at two dose levels (2.4mg/2.4mg & 1mg/1mg) vs semaglutide (2.4 & 1mg), cagrilintide (2.4mg) alone, & PBO in 2,728 pts with T2D inadequately controlled with metformin ± an SGLT2 inhibitor
At 68wks., CagriSema (2.4/2.4mg) outperformed semaglutide (2.4mg), reducing HbA1c by…
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Ascletis Pharma reported that the first participants have been dosed in a US 13-week P-II study of ASC30, an oral small-molecule GLP-1 receptor agonist, for the treatment of type 2 diabetes mellitus, with topline data expected in Q3’26
The study will enroll ~100 pts and evaluate ASC30’s effects on HbA1c as a 1EP, and…
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The U.S. FDA has accepted the NDA for Novo's CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention
NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone,…
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Gan & Lee Pharmaceuticals has initiated a P-III (GRADUAL-3) study of bofanglutide (GZR18) in adults with obesity or overweight
The trial will assess the safety & efficacy of bofanglutide (SC, Q4W) in obese or overweight pts for 24wks., while evaluating the change and the percentage change from baseline in body weight at 24wk. as…

