Aldyxin's 2025 Patent expiry

One of the more recent patent expirys for GLP1 Receptor Agonists coming up is Aldyxin, which is the popular name for the peptide Lixisenatide:

Lixisenatide - Wikipedia

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What is Aldyxin?

Aldyxin is a GLP1 Receptor Agonist manufactured by Sanofi, a large French pharmaceutical company:

Aldyxin is sometimes sold under the brand name Lyxumia:

You can read Sanofi's guide for prescribing Aldyxin online.

How has Aldyxin been prescribed in the past?

While of course prescriptions are a matter that is trusted to health professionals, the FDA publishes guidelines on products and treatments – which we can dig into and read.

Click here to read the FDA prescribing advice for Aldyxin.

How effective was Aldyxin/Lixisenatide

While the most effective GLP1s on the market at present continue t0 be Semaglutide and Tirzepatide, Lixisenatide is a similar compound, and one might expect it to have similar efficacy.

Unfortunately Lixisenatide has had less scrutiny in terms of it's effects on weight loss and more on other diseases, like Parkinsons:

Trial of Lixisenatide in Early Parkinson’s Disease - PubMed

In participants with early Parkinson’s disease, lixisenatide therapy resulted in less progression of motor disability than placebo at 12 months in a phase 2 trial but was associated with gastrointestinal side effects. Longer and larger trials are needed to determine the effects and safety of lixisen …

PubMedWassilios G Meissner

Also, similar to other GLP1s Lixisenatide has shown results in decreasing HBA1c:

Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes - PubMed

This meta-analysis demonstrates that lixisenatide in combination with oral anti-diabetic therapy significantly improves outcomes combining efficacy and safety parameters in patients with T2DM.

PubMedDenis Raccah

There are some papers that focus on the potential for Lixisenatide to affect weight loss, however, and we can rely on the meta-analysis that was published:

The effect of subcutaneous Lixisenatide on weight loss in patients with type 2 Diabetes Mellitus: Systematic review and Meta-Analysis of randomized controlled trials - PubMed

Lixisenatide was found to significantly decrease BW and BMI in patients with type 2 DM and could be considered as a therapeutic option for those suffering from weight gain caused by other anti-diabetic agents. However, while prescribing Lixisenatide, careful consideration of patient-specific factors …

PubMedLei Sheng

Results: 23 articles with 26 RCT arms were included in the meta-analysis. The combined findings from a random-effects model demonstrated a significant reduction in body weight (WMD: -0.97 kg, 95 % CI: -1.10, -0.83, p < 0.001) and BMI (WMD: -0.48 kg/m², 95 % CI: -0.67, -0.29, P < 0.001) after subcutaneous administration of Lixisenatide. Furthermore, a more pronounced reduction in body weight was discovered in RCTs lasting less than 24 weeks (WMD: -1.56 kg, 95 % CI: -2.91, -0.20, p < 0.001), employing a daily dosage of subcutaneous Lixisenatide lower than 19 µg per day (WMD: -1.94 kg, 95 % CI: -2.54, -1.34, p < 0.001) and with a mean participant age of 60 years or more (WMD: -1.86 kg, 95 % CI: -3.16, -0.57, p = 0.005).

While it's a little unclear just how much weight was lost, this goes to show just how much the weight loss was not in focus.

What happens after Aldyxin is released from it's patents?

The exciting news here is that after Aldyxin is released from it's patents, it will be possible for new pharmaceutical companies to evaluate and possibly pursue Lixisenatide and other combinations/formulations of it in order to

Lixisenatide, though largely unrecognized in the GLP1 market now could be the base of new and impressive formulations that increase the supply of available GLP1s.

While much of the news is focusing on completely new formulations developed by larger corporations, the expiration of patents can also offer new avenues for drug discovery – for example, researchers exploring combining an already patent-free Liraglutide with something like Lixisenatide might produce an entirely new kind of combination drug.

That said, it may also be that Lixisenatide bears fundamental limitations that make it not suitable as a long term platform or a great GLP1 receptor agonist. Only time (and research) can tell.