Rybelsus by Novo Nordisk for Obesity: Likelihood of Approval

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Rybelsus is under clinical development by Novo Nordisk and currently in Phase III for Obesity. According to GlobalData, Phase III drugs for Obesity have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Rybelsus’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Rybelsus overview

Semaglutide (Rybelsus) is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 produced by yeast fermentation, acts as an anti-diabetic agent. It is formulated as tablets for oral route of administration. Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Rybelsus is also indicated in reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

Rybelsus is under development for the treatment of type 2 diabetes and obesity. It is being developed based on DehydraTECHTM technology.

Novo Nordisk overview

Novo Nordisk, a subsidiary of Novo Holdings AS, is a healthcare company focused on discovering, developing, and manufacturing of innovative biological medicines. It focuses on advancing drugs for the treatment of diabetes and other serious chronic conditions, including hemophilia, human growth hormone (HGH) disorders, rare blood and rare endocrine diseases, and obesity. The company’s portfolio includes pre-filled delivery systems for insulin; glucagon hypokit; cartridge; needles; vials; insulin; estradiol for hormone replacement; recombinant drugs for hemophilia; glucagon; and oral antidiabetic agents. The company markets its products through subsidiaries in North America, Europe, Asia, Latin America, Africa, the Middle East and Australia. Novo Nordisk is headquartered in Bagsvaerd, Denmark.

For a complete picture of Rybelsus’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.

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