Evidence map›Paper›PMID 34024013›Full record

ArticleDrug delivery and translational research2022

Development and approval of rybelsus (oral semaglutide): ushering in a new era in peptide delivery.

Andrew L Lewis, Nicholas McEntee, Justin Holland, Asma Patel

Abstract read
PubMed Publisher
In one paragraph

Article in Drug delivery and translational research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

  1. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
    Pooled it
  2. Article
  3. Review
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  7. Tableting of nanoparticle-based formulations for oral delivery: Enhancing biopharmaceutical performance.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
    Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Enhanced macromolecule bioavailability in rats and pigs using an in situ forming synthetic epithelial lining.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Article
  13. Review
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  19. Article
  20. Gastrointestinal Permeation Enhancers Beyond Sodium Caprate and SNAC - What is Coming Next?Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Andrew L LewisQuotient Sciences, Mere Way Ruddington, Nottingham, NG11 6JS, UK. Andrew.Lewis@quotientsciences.com.
Nicholas McEnteeQuotient Sciences, Mere Way Ruddington, Nottingham, NG11 6JS, UK.
Justin HollandQuotient Sciences, Mere Way Ruddington, Nottingham, NG11 6JS, UK.
Asma PatelQuotient Sciences, Mere Way Ruddington, Nottingham, NG11 6JS, UK.
Quotient Clinical (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Achieving efficacious systemic levels of orally administered peptides is incredibly challenging due to the significant barriers to their bioavailability-their stability in the gastrointestinal tract and challenge of transepithelial transit, and variable pharmacokinetics. Even so, as the generally preferred route of administration, significant research effort in academic and industrial settings has focused on enabling the systemic absorption of orally delivered peptides. Despite several decades of research, few have ever reached the market. The recent approval of Rybelsus® (oral semaglutide) by the FDA [1], the EMA [2], and the Pmda [3] represents a significant landmark in the delivery of therapeutic peptides and is the culmination of more than 30 years research and development of the drug delivery technology enabling the product-Emisphere's Eligen™ technology-and an outstanding commitment to scientific, technical, and clinical innovation by Novo Nordisk. Following years of fundamental and applied research, an innovative clinical strategy led to the aptly named PIONEER clinical programme. This included ten Phase 3 clinical trials that demonstrated the tablet formulation to be as effective as the already approved injectable form of the drug, and more effective than competitor products in terms of its blood glucose lowering effects and weight loss. Not only is this a potentially life changing medicine for diabetic patients, it holds tremendous commercial potential for Novo Nordisk, with some analysts predicting the product to reach $5 billion in peak revenues [3]. In this "Inspirational Note," we summarize some of the public domain work that led to the achievement of this significant milestone and provide commentary on its potential future impact.

Indexed as

Diabetes Mellitus, Type 2Administration, OralBlood GlucoseGlucagon-Like PeptidesHumansHypoglycemic AgentsPeptidesSemaglutideBlood GlucoseGlucagon-Like PeptidesHypoglycemic AgentsPeptidesSemaglutide

Identifiers

PMID34024013
OpenAlexW3165233596

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.