Avexitide_Dosage, benefits & legal status
Also known as exendin (9-39), exendin 9-39, Ex-9, avexitide acetate
Exenatide with its first eight residues removed, so it blocks the receptor instead of switching it on. A phase 3 succeeded in August 2026.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Avexitide?
Plain language first. The technical label stays, but it never stands alone.Overview
After gastric bypass, food rushes into the gut, GLP-1 surges and the pancreas releases far too much insulin, so blood sugar can crash an hour or two after eating. Blocking the GLP-1 signal damps that insulin spike. In the 78-person LUCIDITY phase 3, clinically significant and severe low blood sugar events (Level 2 and 3) fell 55% against placebo. It is not approved anywhere; Amylyx plans to file with the FDA by the end of 2026.
Avexitide is exendin (9-39), the 31-residue tail of exendin-4 (exenatide) without the eight residues that activate the GLP-1 receptor, so it binds the receptor and blocks it. Stanford researchers developed it for hyperinsulinaemic hypoglycaemia; Eiger BioPharmaceuticals ran the early trials, and Amylyx Pharmaceuticals bought it out of Eiger's bankruptcy in 2024.
What it's used for
An experimental daily injection for post-bariatric hypoglycaemia, the after-meal blood sugar crashes some people get after gastric bypass. It is not a weight-loss drug.
How does Avexitide work?
What it does in the body, and where.Avexitide sits in the GLP-1 receptor without switching it on, the opposite of exenatide and semaglutide.
- 01Why bypass causes crashesAfter gastric bypass, food reaches the small intestine fast and triggers very large GLP-1 surges. GLP-1 pushes the pancreas to release too much insulin, and 1 to 3 hours after eating, blood sugar can fall to dangerous levels.
- 02A headless copyExenatide's first eight residues are what activate the GLP-1 receptor. Avexitide is residues 9 to 39 only, so it binds the receptor and blocks GLP-1 from it. In lab tests it is half-maximally effective at about 20 to 30 nanomolar.
- 03Smaller insulin spikesWith the receptor blocked, after-meal insulin peaks fall and the lowest glucose reading rises. In a 2014 study, intravenous exendin (9-39) corrected the lows in all 9 hypoglycaemic bypass patients tested.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Phase 3 LUCIDITY
Investigational- Human trial78 adults after gastric bypass: Level 2 and 3 hypoglycaemia events fell 55% against placebo over 16 weeks (p=0.000003).
- No dataThese are topline company figures; the full data and side-effect rates are not yet published.
Phase 2 trials
Investigational- Human trialPREVENT, 18 women: the lowest after-meal glucose rose 21 to 26% and insulin peaks fell about a fifth against placebo.
- Human trialPhase 2b, 16 people after various stomach surgeries: Level 3 events per two weeks fell from 2.5 to 0.9 on 90 mg daily, in an open-label design.
How the idea was proven
Investigational- human-earlyIntravenous exendin (9-39) corrected hypoglycaemia in all 9 affected bypass patients and cut their insulin secretion by half.
The phase 3 dose is 90 mg once daily, not twice daily; 45 mg twice daily was a phase 2b arm. The 55% reduction is against placebo in the double-blind phase 3; the 53 to 57% (Level 2) and 66 to 68% (Level 3) figures are falls from baseline in the small open-label phase 2b. LUCIDITY enrolled 78 people; the registry still shows the planned 75. It is not approved: the FDA filing is planned for late 2026. It blocks the GLP-1 receptor and does not cause weight loss. Exendin (9-39) is the same molecule whether it is called a fragment of exendin-3 or exendin-4. MBX's imapextide is no longer a near-term competitor for this use: in May 2026 MBX said it would not fund a phase 2b in post-bariatric hypoglycaemia.
The published record
Papers and trials about Avexitide
90 papers tagged human · 25 not reviews or lab · 11 clinical trial publications
57 registered trials · 13 with posted results
Furthest stage reached: Phase 3, LUCIDITY (NCT06747468), double-blind part completed July 2026, extension under way
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Avexitide
Evidence
Investigational
Category
Weight loss and metabolic
Common vial
Varies
Half-life
About 3.6 to 9 hours under the skin (patent data)
How much, and do you cycle it?
The range, and whether you take breaks.90 mg once daily (phase 3 dose), once daily, at least an hour before breakfast. Continuous in the trials Trial dose
Given every day, for 16 weeks double-blind and then up to 32 more weeks open-label; post-bariatric hypoglycaemia is long-lasting.
About 3.6 to 9 hours under the skin (patent data)Trial protocol
Absorption-limited: 3.6 hours at a lower concentration and 9.1 hours at a higher one. Given into a vein it lasts about 33 minutes. No peer-reviewed or label half-life has been published.
Source: US patent application 20240000894 (Eiger and Stanford)
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Avexitide keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 32% charged residues, 45% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Use for weight loss: it blocks GLP-1's effect on insulin and caused no weight change in the phase 3
- Use alongside GLP-1 drugs such as semaglutide or tirzepatide, whose action at the same receptor it opposes
- Pregnancy or breastfeeding, with no data
- Use outside a trial or expanded-access programme: it is not approved anywhere
Stop and get help
- Confusion, sweating, shaking or fainting from low blood sugar: it still needs fast-acting glucose and emergency help
- Swelling of the face or throat, or trouble breathing
Common effects
- Diarrhoea, injection-site redness and injection-site bruising were the most common side effects in the phase 3; rates not yet published
- No avexitide-related serious adverse events and no change in body weight in the 16-week phase 3
- Injection-site bruising in 35 to 47% and loose stools in 24 to 29% in a 17-person phase 2b
- Headache in 12% in the phase 2b
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Avexitide approved?
And where the numbers on this page come from.No. Avexitide is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin (subcutaneous)
- Checked14 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesAmylyx, LUCIDITY phase 3 topline results (SEC 8-K exhibit 99.1, 18 Aug 2026)ClinicalTrials.gov, LUCIDITY (NCT06747468)FDA GSRS substance record, avexitide (UNII 5313W10MYT)Craig CM et al., Journal of Clinical Endocrinology & Metabolism 2021;106:e3235-e3248 (PREVENT)ClinicalTrials.gov, phase 2b posted results (NCT04652479)Salehi M et al., Gastroenterology 2014;146:669-680Amylyx, LUCIDITY trial design and phase 2 results (2024)Amylyx, ENDO 2025 data (13 Jul 2025)Amylyx, acquisition of avexitide from Eiger (10 Jul 2024)US patent application 20240000894 (Eiger and Stanford)MBX Biosciences, obesity portfolio update (11 May 2026)Amylyx, LUCIDITY results call slides (SEC 8-K exhibit 99.1, Aug 2026)Amylyx, LUCIDITY topline data at ObesityWeek (6 Oct 2026)
What has happened recently
Not approved anywhere. On 18 August 2026 Amylyx reported that the LUCIDITY phase 3 (NCT06747468) met its primary endpoint; it plans an FDA application by the end of 2026, with a possible US launch in 2027 if approved, and the topline results will be presented as a late-breaking talk at ObesityWeek on 15 November 2026. The FDA granted breakthrough therapy designation for post-bariatric hypoglycaemia (2019) and congenital hyperinsulinism (2021), plus orphan and rare paediatric disease designations; the EU granted orphan designation. Stanford licensed it to Eiger BioPharmaceuticals in 2015; after Eiger's bankruptcy Amylyx bought it for $35.1 million in July 2024, with a 3% royalty owed to academic institutions. An expanded-access programme opened in May 2026.
You can compare this against the whole library, or read how to check a seller.
What else is like Avexitide?
Others in Weight loss and metabolic, side by side.If you're weighing Avexitide, it's worth reading Metreleptin (Myalept), Semaglutide, and Tirzepatide in the same class.
Exenatide with its first eight residues removed, so it blocks the receptor instead of switching it on. A phase 3 succeeded in August 2026.
- Dose
- 90 mg once daily (phase 3 dose)
- How often
- Once daily, at least an hour before breakfast
A recombinant copy of human leptin, injected daily to stand in for the hormone missing in lipodystrophy. Not a weight-loss drug.
- Dose
- 2.5 to 10 mg daily over 40 kg; 0.06 to 0.13 mg/kg at 40 kg or under (label)
- How often
- Once daily
The drug in Ozempic and Wegovy: a weekly shot that curbs hunger for steady weight loss.
- Dose
- 0.25 up to 2.4 mg per week (start low, increase slowly)
- How often
- Weekly
The drug in Mounjaro and Zepbound: a weekly shot for major weight loss and blood sugar.
- Dose
- 2.5 up to 15 mg per week (start low, increase slowly)
- How often
- Weekly
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- Amylyx, LUCIDITY phase 3 topline results (SEC 8-K exhibit 99.1, 18 Aug 2026)(2026)78 adults with post-bariatric hypoglycaemia after gastric bypass: Level 2 and 3 hypoglycaemia events down 55% against placebo (p=0.000003) at 90 mg daily; all secondary endpoints met; FDA application planned by the end of 2026.
- ClinicalTrials.gov, LUCIDITY (NCT06747468)(2026)Randomised 3:2, double-blind, placebo-controlled, 16 weeks, 21 US sites, then a 32-week open-label extension; 90 mg once daily before breakfast.
- FDA GSRS substance record, avexitide (UNII 5313W10MYT)(2026)Exendin (9-39) amide, 31 residues; C149H234N40O47S, MW 3369.76; CAS 133514-43-9; US and EU orphan codes.
- Craig CM et al., Journal of Clinical Endocrinology & Metabolism 2021;106:e3235-e3248 (PREVENT)(2021)18 women after gastric bypass, placebo-controlled crossover: glucose nadir up 21% and 26%, insulin peak down 21 to 23%.
- ClinicalTrials.gov, phase 2b posted results (NCT04652479)(2023)Open-label, 16 analysed: Level 2 events per 14 days 5.2 at baseline against 2.1 on 90 mg daily; Level 3 2.5 against 0.9. Injection-site bruising 35 to 47%.
- Salehi M et al., Gastroenterology 2014;146:669-680(2014)Intravenous exendin (9-39) corrected after-meal hypoglycaemia in all 9 hypoglycaemic bypass patients; insulin secretion fell 50%.
- Amylyx, LUCIDITY trial design and phase 2 results (2024)(2024)Breakthrough therapy, orphan and rare paediatric disease designations; phase 2b reductions of 53% and 66% in Level 2 and 3 events against baseline.
- Amylyx, ENDO 2025 data (13 Jul 2025)(2025)In vitro IC50 about 20 to 30 nM; modelling shows 90 mg daily keeps levels above it for 24 hours.
- Amylyx, acquisition of avexitide from Eiger (10 Jul 2024)(2024)Bought for $35.1 million in July 2024, with a 3% royalty on post-bariatric hypoglycaemia sales owed to academic institutions.
- US patent application 20240000894 (Eiger and Stanford)(2024)Half-life about 33 minutes intravenously and 3.6 to 9.1 hours under the skin, depending on concentration.
- MBX Biosciences, obesity portfolio update (11 May 2026)(2026)MBX will not fund a phase 2b of imapextide, a rival weekly GLP-1 blocker, in post-bariatric hypoglycaemia.
- Amylyx, LUCIDITY results call slides (SEC 8-K exhibit 99.1, Aug 2026)(2026)Rate ratio 0.45 (95% CI 0.32 to 0.63); more than 90% completed the 16-week double-blind period.
- Amylyx, LUCIDITY topline data at ObesityWeek (6 Oct 2026)(2026)Late-breaking oral presentation of the topline phase 3 results on 15 November 2026.
Beyond these, 119 records are indexed. Browse the records