A Phase 3, Randomised, Open-label, Cross-over Study to Confirm the Clinical Efficacy and Safety of Dasiglucagon Versus Glucagon for the Treatment of Severe Hypoglycaemia in Asian Adults With Type 1 Diabetes (T1D) Including an Investigation of Dasiglucagon in a Japanese Adolescent Cohort

This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D. This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon. Participants will get dasiglucagon and glucagon. In which treatment order participants get study medicines (dasiglucagon and glucagon) is decided by chance. Dasiglucagon is a new medicine, but doctors can prescribe it in the US as it is approved there. Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine. The study will last for about 17 weeks. Participant cannot be in the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding, plan to get pregnant, during the study period, or not using adequate contraceptive methods. For man: if participant have sex, participant and his partner must use an adequate birth control method during the study.

Start Date10 Sep 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT05454709

/ WithdrawnPhase 2

A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study

The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.
This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

Start Date29 Dec 2023

Sponsor / Collaborator

Inreda Diabetic BV

NCT05378672

/ RecruitingPhase 3

Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)

This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.) into the buttocks.
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

Start Date09 May 2023

Sponsor / Collaborator

Zealand Pharma US, Inc.

[+1]

100 Clinical Results associated with Dasiglucagon

100 Translational Medicine associated with Dasiglucagon

100 Patents (Medical) associated with Dasiglucagon

Literatures (Medical) associated with Dasiglucagon

22 Apr 2025·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Letter to the Editor From He et al: “Dasiglucagon in Children With Congenital Hyperinsulinism up to 1 Year of Age: Results From a Randomized Clinical Trial”

Communications

Author: Wang, Chenxi ; Tian, Huichuan ; He, Ziyi

22 Apr 2025·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Response to Letter to the Editor From He et al: “Dasiglucagon in Children With Congenital Hyperinsulinism up to 1 Year of Age: Results From a Randomized Clinical Trial”

Communications

Author: Thornton, Paul S ; Birch, Sune ; Kendall, David M ; De Leon, Diva D ; Kummer, Sebastian ; Ivkovic, Jelena ; Banerjee, Indraneel ; Bøge, Eva

01 Apr 2025·Endocrinology Diabetes and Metabolism Case Reports

Necrolytic migratory erythema following prolonged continuous subcutaneous dasiglucagon administration: a rare dermatologic adverse event

Article

Author: Rutsch, Frank ; Weschle, Lucas ; Oesingmann, Sandra ; Potratz, Jenny ; Pascher, Andreas ; Busch, Alexander S ; Masjosthusmann, Katja ; Humberg, Alexander

Summary:

Clinical management of congenital hyperinsulinism (CHI) remains a significant challenge due to its complex pathophysiology and the limitations of available therapies. Dasiglucagon, a synthetic glucagon analog, represents a novel approach to managing CHI, particularly in patients where conventional therapies fail. This report discusses a rare case of prolonged continuous subcutaneous dasiglucagon use in a neonate with CHI. Despite initial stabilization of glycemic levels, the patient developed necrolytic migratory erythema (NME), a rare dermatological condition associated with hyperglucagonemia, during dasiglucagon therapy. The patient further experienced severe malnutrition, zinc and amino acid deficiencies, and sepsis. Following the discontinuation of dasiglucagon therapy due to these severe side effects, the patient’s skin and nutritional status improved markedly. However, glycemic control required subtotal pancreatectomy. This report underscores the potential of dasiglucagon in CHI management but highlights the importance of close monitoring during prolonged therapy.

Learning points:

NME, a rare but severe condition, appears to be associated with prolonged continuous subcutaneous dasiglucagon therapy, requiring early recognition and intervention.Close monitoring is essential during prolonged continuous subcutaneous dasiglucagon therapy to detect potential adverse effects, focusing on dermatological conditions, nutrient deficiencies or signs of infection.Multidisciplinary care is crucial to manage CHI with dasiglucagon, ensuring a comprehensive approach that addresses both glycemic control and potential side effects.

News (Medical) associated with Dasiglucagon

20 Feb 2025

·www.globenewswire.com

Zealand Pharma Announces Financial Results for the Full Year 2024

Company announcement – No. 2 / 2025 Zealand Pharma Announces Financial Results for the Full Year 2024 A transformational year with significant clinical advancement across differentiated obesity pipeline, while building the foundation for accelerated growth in the years to come Positive results with long-acting amylin analog petrelintide in 16-week Phase 1b trial and advancement into large, comprehensive Phase 2b trial in people with overweight or obesity Positive topline results with GLP-1/GLP-2 receptor dual agonist dapiglutide in 13-week Phase 1b trial and expansion of trial to investigate higher doses over a longer treatment period Positive results with glucagon/GLP-1 receptor dual agonist survodutide in Boehringer Ingelheim Phase 2 trial in MASH and advancement into largest Phase 3 MASH program with an incretin-based therapy DKK 8.5 billion (USD 1.2 billion) secured through two equity raises enabling significant investments in R&D pipeline and organizational capabilities Copenhagen, Denmark, February 20, 2025 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced financial results for the year ended December 31, 2024 and provided a corporate update. Driving innovation in obesity with differentiated mid- to late-stage pipeline “2024 was a transformational year for Zealand Pharma with positive data across our mid- to late-stage obesity pipeline and significant capital raised to further invest in our pipeline and the organization, preparing the company for the next phase of growth,” said Adam Steensberg, President and Chief Executive Officer at Zealand Pharma. “From this very solid foundation, both financially and organizationally, we expect accelerated momentum in 2025 with important clinical advancement of our obesity programs.” Key financial results for FY 2024 DKK millionFY 2024FY 2023Revenue62.7342.8Net operating expenses1-1,327.0-895.9Net operating result-1,272.2-572.2Net financial items188.8-136.6Cash position29,022.01,633.1 Notes:1. Net operating expenses consist of R&D, S&M, G&A and other operating items.2. Cash position includes cash, cash equivalents and marketable securities. Financial guidance for 2025 The strong cash position enables Zealand Pharma to significantly accelerate its investments in the company’s wholly-owned obesity programs, which in 2025 will include three large Phase 2b trials. Net operating expenses expected in 2025 are mostly driven by research and development. Development costs primarily relate to the clinical advancement of the wholly-owned obesity programs, including Phase 2b trials, CMC activities related to API and Drug Product, as well as Phase 3 preparations. Research costs are mainly driven by enhanced investments in next-generation peptide therapeutics focused on obesity and inflammation. DKK million 2025 Guidance2024 ActualRevenue anticipated from existing and new license and partnership agreementsNo guidance62.7Net operating expenses32,000 – 2,5001,327.0 Notes:3. Financial guidance based on foreign exchange rates as of February 19, 2025. Highlights of the year and key events anticipated in 2025 Obesity – advancing the differentiated pipeline Petrelintide, a long-acting amylin analog. Zealand Pharma reported positive results from the 16-week Phase 1b trial with petrelintide and presented the data at the Obesity Society Annual Meeting (ObesityWeek). In December 2024, the company subsequently initiated ZUPREME-1, a large, comprehensive Phase 2b trial in people with overweight or obesity and anticipates completion of participant enrolment in the first half of 2025. The company also expects to expand the development program of petrelintide by initiating ZUPREME-2, a Phase 2b trial in people with overweight or obesity and type 2 diabetes in the first half of 2025. Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist. Zealand Pharma reported positive topline results from the 13-week Phase 1b trial with dapiglutide, providing support for advancing this candidate into a large Phase 2b trial in people with overweight or obesity, which is planned for initiation in the first half of 2025. The company also expanded the Phase 1b trial to evaluate higher doses of dapiglutide over a longer treatment period, with topline results from this part of the trial expected in the first half of 2025. Survodutide, a glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim reported positive results from the Phase 2 trial with survodutide in MASH, presented the data at the European Association for the Study of the Liver (EASL), and received a Breakthrough Therapy Designation from the U.S. FDA. Boehringer Ingelheim subsequently initiated two large registrational Phase 3 trials with survodutide in people with MASH; LIVERAGE™ in people with moderate or advanced liver fibrosis (stages 2 or 3) and LIVERAGE™-Cirrhosis in people with compensated cirrhosis (fibrosis stage 4). In 2024, Boehringer Ingelheim also completed participant enrolment for SYNCHRONIZE™-1 and SYNCHRONIZE™-2, the Phase 3 clinical trials of survodutide in people with overweight or obesity without and with type 2 diabetes, respectively. Rare diseases – long-term commitment to patients with CHI and SBS Dasiglucagon in congenital hyperinsulinism (CHI). Zealand Pharma is prepared to resubmit the New Drug Application (NDA) for three weeks of dosing to the U.S. FDA contingent on the third-party manufacturing facility receiving an inspection classification upgrade. Subsequently, Zealand Pharma also expects to submit the required and detailed analyses from existing continuous glucose monitoring datasets to support the use of dasiglucagon beyond three weeks. Glepaglutide in short bowel syndrome (SBS). In December 2024, Zealand Pharma received a Complete Response Letter (CRL) for the NDA for glepaglutide, a long-acting GLP-2 analog under development for the treatment of adults with SBS with intestinal failure. In 2025, the company expects to initiate a single placebo-controlled Phase 3 trial (EASE-5) to provide further confirmatory evidence for a regulatory submission in the U.S. and to support regulatory submissions for glepaglutide in geographies outside the U.S. and the EU. In parallel, Zealand Pharma anticipates proceeding with current plans to submit a Marketing Authorization Application to support EU approval. Chronic inflammation – progressing the pipeline ZP9830, Kv1.3 ion channel blocker. Zealand Pharma initiated the first-in-human clinical trial with ZP9830, a Kv.1.3 ion channel blocker in late 2024 and anticipates completing this trial in 2025. The company believes this candidate holds potential to treat a broad range of cell-mediated autoimmune diseases. Sustainability – building a sustainable organization In 2024, Zealand Pharma launched a refined sustainability strategy and developed a Climate Change Transition Plan, outlining activities and targets for climate change mitigation. The company will further accelerate its sustainability efforts in 2025, with key focus areas including the expected submission of the Climate Change Transition Plan to the Science Based Targets Initiative and continued preparations for the EU’s Corporate Sustainability Reporting Directive. Zealand Pharma achieved notable organizational growth in 2024 with a 30% increase in the number of employees compared to 2023. Yet, the company maintained its high employee engagement score of 8.8/10 and decreased the employee turnover rate from 10.3% in 2023 to 7.3% in 2024. Conference call today at 2 PM CET / 8 AM ET Zealand Pharma’s management will host a conference call today February 20 at 2:00 PM CET / 8:00 AM ET to present results for the full year 2024 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; Chief Medical Officer, David Kendall; and Chief Commercial Officer, Eric Cox. The conference call will be conducted in English. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/96nk8pep. To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI735075144114493ead489441f1d0740f. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand Pharma’s website at https://www.zealandpharma.com/investors/events-presentations/. About Zealand Pharma Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com. Forward looking statements This company announcement contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development, and commercialization of pharmaceutical products, the timing of the company’s clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would”, and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Contacts Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: akrassowska@zealandpharma.com Adam Lange (Investors)Investor Relations OfficerZealand PharmaEmail: alange@zealandpharma.com Neshat Anis Ahmadi (Investors)Investor Relations ManagerZealand PharmaEmail: neahmadi@zealandpharma.com Attachment Zealand Pharma 2024 Annual Report

Phase 2Clinical ResultPhase 3Breakthrough TherapyFinancial Statement

22 Jan 2025

·www.fiercepharma.com

Xeris, stymied by forgetful physicians, partners with ADA to raise awareness of need for glucagon

The roadmap covers problems that Xeris has identified as barriers to growth of Gvoke. Xeris Pharmaceuticals has teamed up with the American Diabetes Association (ADA) to raise awareness of the importance of prescribing glucagon, positioning the partners to address a fundamental barrier to the use of products such as its Gvoke.The FDA approved Gvoke, a ready-to-use glucagon product, for the treatment of severe hypoglycemia in 2019. The format is potentially more convenient than traditional glucagon kits from the likes of Fresenius Kabi and Amphastar, but Xeris has struggled to penetrate the vast opportunity. Xeris said it ended 2024 with a 35% market share, but the vast majority of people at risk of low blood glucose don’t carry an emergency kit.Supported by Xeris, the ADA wants to rectify low rates of glucagon prescriptions. The multi-year pact between the organizations will support development of education materials and training resources for healthcare professionals and people living with diabetes. A push to educate those groups on who is at risk for severe hypoglycemia and should have glucagon is also on the agenda.The roadmap covers problems that Xeris has identified as barriers to the growth of Gvoke. ADA guidelines state that “glucagon should be prescribed for all individuals taking insulin or at high risk for hypoglycemia” and that ready-to-use preparations are preferred. Despite that, uptake of Gvoke and rival ready-to-use kits is low. Speaking at a Piper Sandler event last month, Kevin McCulloch, chief operating officer at Xeris, estimated that 15 million people with diabetes in the U.S. are at “outsized risk of having their blood sugar go too low.” Yet, McCulloch said, only around 1 million people carry a glucagon product—and he claimed to know why.“We find that the No. 1 reason that a prescriber doesn't prescribe Gvoke might surprise you: It’s they don't remember. It isn't any of the other things that you might traditionally associate with barriers to the adoption of pharmaceuticals. It's actually in remembering,” McCulloch said. “Very busy clinicians treating diabetes have a hard time remembering something like this that's brand new.”According to McCulloch, Xeris is the only glucagon company “out there advocating for the new guidelines and promoting in the space.” Amphastar's intranasal glucagon dry powder, Baqsimi, and Novo Nordisk’s dasiglucagon auto-injector, Zegalogue, compete with Gvoke. McCulloch said he had yet to see the rivals make a big contribution to the awareness push as of last month.“We're still really not hearing much from others, and we'd welcome more noise out there to create more awareness,” McCulloch said. “We think this is really just the reason for the delta between who has it and who should have it.”

Drug Approval

08 Nov 2024

·medcitynews.com

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market - MedCity News

A pharmaceutical ingredient that’s been a key component in nasal decongestants for decades is having its efficacy called into question, and the FDA is now weighing whether to change the compound’s regulatory status — potentially leading to many widely used over-the-counter cold and allergy products being pulled from pharmacy shelves. But before the FDA takes any action, it wants to hear what the public thinks. The ingredient, oral phenylephrine, by itself and in combination with other active ingredients, is in decongestants sold under numerous brand names, such as Sudafed and Mucinex. All products containing oral phenylephrine continue to be available to consumers for now. But on Thursday, the FDA proposed an order that would remove oral phenylephrine from its non-prescription drugs guidelines, called the OTC Monograph. The regulator emphasized that this proposed order is due to lack of efficacy, not because of safety. At one time, phenylephrine was rare in decongestants because pseudoephedrine was the preferred active ingredient. But that compound can be made into the methamphetamine. Efforts to curb meth production led to the Combat Methamphetamine Act of 2005, which moved pseudoephedrine-containing drugs behind pharmacy counters. Drugmakers responded by making more products with oral phenylephrine, which is not covered by this law. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Last year, an FDA advisory committee discussed phenylephrine and unanimously voted that current scientific data do not support the ingredient’s efficacy as a nasal decongestant. The committee raised no concerns about the safety of oral phenylephrine when used at the recommended dose. The FDA now says it has conducted a comprehensive review of all available safety and efficacy data for oral phenylephrine as a nasal decongestant, including historical data used to support the compound 30 years ago. Speaking during a conference call with journalists Thursday, Theresa Michele, director of the FDA’s office of nonprescription drugs, said new data had become available since the advisory committee meeting, which the agency also reviewed. “At this point, based on the available data, and taking into account the advice of the advisory committee, we are proposing that oral phenylephrine is not effective to relieve nasal congestion at the recommended dose set forth in the monograph,” Michele said. Phenylephrine is also an ingredient in some nasal spray decongestants. The FDA’s proposal does not extend to such products. The proposed FDA order can be found here. Public comments may be submitted here (use docket number FDA-2024-N-4734 ) through May 7, 2025. After considering the comments, the agency may issue a final order removing oral phenylephrine from its guidelines, which would mean nasal decongestants could no longer contain the compound. Michele said the FDA would then provide manufacturers with time to either reformulate their medicines or remove oral phenylephrine-containing products from the market. Don’t let the autumn sniffles get you down. Here’s a look back at other recent regulatory news, including U.S. and European actions on several novel medications (alas, no new decongestants): Exclusive Heard at HLTH 2024: Insights from Innovative Healthcare Executives Executives from Imagine360, Verily, BrightInsight, Lantern, and Rhapsody shared their approaches to reducing healthcare costs and facilitating digital transformation. By MedCity News Decisions for Drugs and Devices —The FDA needs more time to review Organon drug Vtama as a treatment for atopic dermatitis. The company said the regulator has pushed out the December target date for a decision by three months to March 12, 2025. Vtama is from Roivant Sciences subsidiary Dermavant, which Organon recently acquired for $175 million up front. Under Dermavant, the topical drug won FDA approval in 2022 as a treatment for plaque psoriasis. —Novartis cancer drug Scemblix expanded its FDA-approved uses to include the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ PML). The tablet, part of a class of drugs called STAMP inhibitors, initially landed accelerated FDA approval in 2021 as a treatment for advanced cases of Ph+ PML. —The FDA approved Iterum Therapeutics antibiotic Orlynvah. The regulatory decision covers the treatment of uncomplicated urinary tract infections in women who have limited or no oral antibacterial treatment options. The drug, whose main ingredient is sulopenem, is taken as a tablet twice daily for five days. —Astellas Pharma landed FDA approval for zolbetuximab, brand name Vyloy, as a treatment for gastric or gastroesophageal junction adenocarcinoma. It’s the first FDA approval for a drug targeting the cancer protein claudin 18.2 (CLDN18.2). The regulatory decision specifically covers patients whose cancer is negative for a different cancer protein called HER2. Drugs are already available for HER2-positive cancers. —In other Astellas news, the Japanese pharma company withdrew its European Medicines Agency application for geographic atrophy drug avacincaptad pegol. The company said it made the decision after discussions with the agency’s Committee for Medicinal Products for Human Use. The drug, administered as a once-monthly eye injection, won FDA approval in geographic atrophy last year and is marketed in the U.S. under the brand name Izervay. Failure to secure approval in Europe will make it harder for Astellas to recoup the $5.9 billion it spent to acquire Iveric Bio, the company that developed the drug. —Pfizer respiratory syncytial virus vaccine Abrysvo expanded its FDA approval to include adults age 18 through 59, broadening the market for the product. The initial FDA approval of Abrysvo last year covered patients age 60 and older. It’s also approved for use by pregnant individuals as a maternal vaccine; antibodies produced by the mother confer protection against RSV intended to last from the baby’s birth up to six months of age. —Gilead Sciences’ Trodelvy will no longer be available in the U.S. for treating urothelial carcinoma, an aggressive bladder cancer. After discussions with the FDA, the company decided to voluntarily withdraw the product, which had won accelerated approval in this indication in 2021. In May, the company reported Trodelvy failed its confirmatory Phase 3 test in advanced urothelial carcinoma. The withdrawal in urothelial carcinoma does not affect drug’s approved uses in breast cancer. —After previous regulatory setbacks, AbbVie finally landed FDA approval for Vyalev, a Parkinson’s disease drug/device combination product that provides 24 hour subcutaneous infusion of the medications foscarbidopa and foslevodopa. Last year, the regulator turned down the product’s application, asking for more information about the pump in the device. The FDA did not raise any questions about safety or efficacy, nor did it ask for another clinical trial. This past June, the agency again turned down AbbVie’s application for issues at the product’s third-party manufacturer. —There’s a new Pfizer drug for both hemophilia A and B. The FDA approved the antibody drug marstacimab for preventing or reducing frequency of bleeding episodes in patients 12 and older. Pfizer will market the drug under the brand name Hympavzi. As a once-weekly injectable medication, Hympavzi will provide an alternative to IV-infused hemophilia therapies. —The FDA needs more time to review Intercept Pharmaceuticals’ application seeking full regulatory approval of Ocaliva, which had received accelerated approval in 2016 for the rare liver disease primary biliary cholangitis. Intercept, now a subsidiary of Alfasigma, said the agency did not provide a new date for a regulatory decision. —Alzheimer’s disease drug Leqembi hit a regulatory obstacle in Australia, where the Therapeutic Goods Administration decided against registering the medication. Eisai said it will request a reconsideration as permitted under Australian law. It’s the second setback for the drug in recent months. Over the summer, the drug received a negative opinion from a European Medicines Agency committee concerned about the risk of severe side effects and limited benefit. Leqembi has approvals in the U.S., Japan, China, and several other markets. —The FDA approved a Thermo Fisher Scientific companion diagnostic to Voranigo, a Servier Pharmaceuticals’ drug approved over the summer for treating patients whose glioma is driven by mutations to IDH1 or IDH2 enzymes. The diagnostic, called Ion Torrent Oncomine Dx Target Test, identifies patients whose cancer carries the genetic signature making them eligible for treatment with the Servier drug. —Advanced cases of non-small cell lung cancer can now be treated with a wearable device. The FDA approved Novocure’s Optune Lua, a wearable technology that kills cancer cells with electrical signals administered via electrodes placed on the skin. Novocure’s “tumor-treating field” technology was first approved in 2011 as a treatment for a recurrent type of brain cancer. —The FDA rejected Zealand Pharma’s dasiglucagon, a drug developed to prevent and treat hypoglycemia in children who have the rare disease congenital hyperinsulinism. According to the Copenhagen-based biotech, the regulator cited issues at a third-party manufacturer. The FDA did not raise any concerns about the drug’s clinical data or safety. Advisory Committee Outcomes —An FDA advisory committee voted 11 to 3 that the benefits of Lexicon Pharmaceuticals’ sotagliflozin do not outweigh its risks when used as an adjunct to insulin to treat adults with type 1 diabetes and chronic kidney disease. But some committee members expressed support for use of the drug in subpopulations of patients. Sotagliflozin, given the brand name Zynquista, is expected to receive an FDA decision by Dec. 20. Sotagliflozin was approved last year for the treatment of heart failure and is marketed as Inpefa in this indication. —The European Medicine Agency’s Committee for Medicinal Products for Human Use yet again recommended against renewing the marketing authorization for Translarna, a PTC Therapeutics drug for Duchenne muscular dystrophy. Translarna received conditional marketing authorization in 2014. After the drug failed its Phase 3 study, the committee twice recommended against renewing the authorization. The latest opinion comes after the EMA directed the committee to reconsider, taking into account “the totality of evidence.” The committee said its reassessment “concluded that the effectiveness of Translarna has not been confirmed.” —Stealth BioTherapeutics moved a step closer to potential approval of the first drug for Barth syndrome. An FDA advisory committee voted 10 to 6 that Stealth’s drug, elamipretide, was effective at treating the ultra-rare mitochondrial disorder. The committee vote follows several regulatory setbacks, including a 2021 refuse-to-file letter in which the FDA pointed out that elamipretide failed its clinical trial. Stealth maintains there was improvement in a subgroup of patients and the short duration of treatment is the reason for the trial failure. An FDA decision is expected by Jan. 29. What’s New in Covid-19 —The European Commission granted marketing authorization to Novavax’s updated Covid-19 vaccine, Nuvaxovid. Authorization for the protein-based vaccine covers its use in those age 12 and older. The FDA authorized the updated version of Novavax’s Covid-19 vaccine in September. —In other Novavax Covid-19 news, the FDA pressed pause on the company’s plans for late-stage testing of a combination flu/Covid-19 vaccine as well as a standalone influenza vaccine. According to Novavax, the clinical hold stems from a report of motor neuropathy in a single patient outside the U.S. who received the combination vaccine in a Phase 2 study. The trial was completed in July 2023 and the serious adverse event was reported in September. Novavax said previous Covid-19 and influenza trials showed no signs of motor neuropathy. The company’s standalone Covid-19 vaccine is unaffected by the clinical hold. —In Covid-19 and flu testing news, the FDA granted marketing authorization to a Healgen Scientific over-the-counter, at-home test for both pathogens. The OTC Healgen Rapid Check Covid-19/Flu A&B Antigen Test uses a sample from a nasal swab. The authorization covers use of the product by people age 14 and older within five days of the start of symptoms. For children as young as 2, the sample must be collected by an adult.

Drug ApprovalPhase 3VaccineAcquisitionClinical Result

100 Deals associated with Dasiglucagon

External Link

KEGG	Wiki	ATC	Drug Bank
D11359	Dasiglucagon	A10BX	DB15226

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypoglycemia	United States	Zealand Pharma US, Inc.	22 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Congenital Hyperinsulinism	NDA/BLA	United States	Zealand Pharma A/S	-
Diabetes Mellitus, Type 1	Phase 3	United States	Zealand Pharma US, Inc.	28 Jun 2017
Diabetes Mellitus, Type 1	Phase 3	Austria	Zealand Pharma US, Inc.	28 Jun 2017
Diabetes Mellitus, Type 1	Phase 3	Canada	Zealand Pharma US, Inc.	28 Jun 2017
Diabetes Mellitus, Type 1	Phase 3	Germany	Zealand Pharma US, Inc.	28 Jun 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EUCTR2020-005241-16-DK (EASD2023)	Phase 2	Hypoglycemia	24	Dasiglucagon 120 µg	umczovidlu(tiifdykpiu): P-Value = 0.002 View more	Positive	04 Oct 2023
				Placebo
NCT03777176 \| NCT04172441 (Biospace) Manual	Phase 3	Congenital Hyperinsulinism	44	Dasiglucagon (NCT04172441)	agcawdtjmg(nlqbeklrcq) = Skin reactions and gastrointestinal disturbances yarlfzzzlk (zjhvyshrpi ) View more	Positive	30 Aug 2023
				Dasiglucagon (NCT03777176)
NCT04764968 (Pubmed)	Phase 2	Hypoglycemia \| Diabetes Mellitus, Type 1	24	Dasiglucagon intervention (DASI)	knxyfiofgu(cvllnacvjp) = Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect zjbeurjzcg (vzktdudxsn )	-	11 Apr 2023
NCT04172441 (ESPE2022) Manual	Phase 2/3	Congenital Hyperinsulinism	12	Dasiglucagon	cspvuqftpe(amrtkteoxg) = ydylipriiu ublydecxmj (zaraknegnr )	Positive	15 Sep 2022
				Placebo	-
NCT04172441 (ESPE 12022 \| ESPE 22022) Manual	Phase 2/3	Congenital Hyperinsulinism	12	Dasiglucagon	yfzujkwepm(qpkketqpoz) = hthtjbpjpz khkffeksjp (jiccuojjph, 4.9)	Positive	15 Sep 2022
				Placebo	yfzujkwepm(qpkketqpoz) = gmnryntqco khkffeksjp (jiccuojjph, 5.6)
ADA2022	Not Applicable	Diabetes Mellitus, Type 1 \| Hypoglycemia	-	Dasiglucagon (Usual Care)	lmdnqyqldn(ahcbqqgsbk) = Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8) honduovsbn (uphsygbjfj )	-	01 Jun 2022
				Dasiglucagon
NCT04172441 (GlobeNewswire) Manual	Phase 3	Congenital Hyperinsulinism	12	Dasiglucagon	reheanalfi(ddhirmbtsn) = lnioqsnsdu qmlkcfzqpz (hypxkauubt )	Positive	19 May 2022
				Placebo	reheanalfi(ddhirmbtsn) = ihkbypknle qmlkcfzqpz (hypxkauubt )
NCT04449692 (Pubmed)	Phase 2	Diabetes Mellitus, Type 1	20	Oral glucose (CHO)	ffsolbvekh(hjefnfgwlw) = Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. fpzvzxnzfl (frtuxsvhyv ) View more	Positive	27 Apr 2022
				Dasiglucagon 80 µg (D80)
NCT03688711 (Pubmed) Manual	Phase 3	Hypoglycemia	45	Dasiglucagon	usfddqulws(eyluyzwhyp) = dqayudrccp mzvtdgvluk (qfqqjlxnka, 8.0 - 12.0) View more	Positive	01 Oct 2021
				Placebo	usfddqulws(eyluyzwhyp) = ahkksfctqn mzvtdgvluk (qfqqjlxnka, 20.0 - NR) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 1	20	Low-dose s.c. dasiglucagon	zgwaannorn(przuwyajpy) = wirkgykpmp hyjfseyajj (jvsdkzzith )	-	01 Jun 2021
				Oral carbohydrates from dextrose tablets	zgwaannorn(przuwyajpy) = vfxbdhmxgh hyjfseyajj (jvsdkzzith )

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