Pegloxenatide (Fulaimei)_Dosage, benefits & legal status
Also known as polyethylene glycol loxenatide, PEG-loxenatide, loxenatide, Fulaimei, PEX168
A weekly GLP-1 whose label says it does not cause weight loss.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Pegloxenatide (Fulaimei)?
Plain language first. The technical label stays, but it never stands alone.Overview
This is a real approved prescription medicine, sold in China since 2019 for type 2 diabetes, and it is the oldest long-acting GLP-1 most Western readers have never heard of. It takes a different route to lasting a week than semaglutide does: instead of a fatty acid that clings to blood proteins, it carries a large polymer that makes the molecule too big for the kidneys to filter out. The reason this page exists is a mismatch. It circulates in English-language discussion as a weight-loss drug because it is a GLP-1, and its own regulatory label says plainly that it produced no significant weight change against placebo in either of the trials it was approved on. The large kilogram figures people quote come from doses well above the approved maximum.
Pegloxenatide is a synthetic 39-residue modified exendin-4 peptide carrying branched polyethylene glycol at a single engineered site. The Chinese package insert describes four backbone changes from native exendin-4, at positions 2, 14, 28 and 39, with the cysteine introduced at position 39 linked through a succinimidyl thioether to a lysine amide bearing two methoxy-PEG arms. Total molecular weight is about 44,200 Da, almost all of it polymer, against a peptide core of roughly 4,000. It is approved in China as a Class 1 chemical drug for adults with type 2 diabetes, alone or with metformin, at 0.1 or 0.2 mg once weekly. It is not a fusion protein. That distinguishes it from the other long-acting exendin derivative on this site.
What it's used for
Approved in China for blood sugar control in adults with type 2 diabetes, alone or added to metformin. It is not approved for weight loss anywhere, and its label reports no significant weight effect.
How does Pegloxenatide (Fulaimei) work?
What it does in the body, and where.Three long-acting GLP-1 strategies exist, and the site now covers all three in exendin-derived form. The differences are not cosmetic: they change what the molecule is, how it is made, and what can go wrong with it.
- 01The peptide is exendin-4 with four changesExendin-4 comes from Gila monster venom and is the basis of exenatide, already covered here. This molecule keeps its 39-residue length and alters four positions, including swapping in a cysteine at the very end to give the polymer something to attach to. So the receptor-facing part is a close relative of a peptide already on the site rather than a new design.
- 02Branched polymer at one site, not a protein partnerA single cysteine thiol carries a linker to a lysine amide holding two polyethylene glycol arms. The result weighs about 44,200 Da, meaning the polymer is roughly nine tenths of the mass. That is a different approach from the other long-acting exendin derivative here, efpeglenatide, a genuine recombinant fusion protein of three chains held together by five disulfide bonds. One is a synthetic peptide plus a synthetic polymer; the other is a protein grown in cells.
- 03Size buys the weekA bare GLP-1 peptide survives minutes, cleared by the kidney and cut by enzymes. Making the molecule far larger defeats kidney filtration, and the polymer shields the peptide from the enzymes. That is the whole half-life strategy, and it is why reduced kidney function changes the drug's clearance enough that its own pharmacokinetic study raised dose adjustment.
- 04What the receptor does, and does not, deliver hereAt the receptor the pharmacology is the class standard: insulin released in proportion to glucose, glucagon suppressed, stomach emptying slowed, appetite reduced. The blood sugar results match that, with HbA1c falling about 1.0 to 1.3 percentage points against placebo. The weight results do not. Its label states no significant body-weight change against placebo in either pivotal trial, and a meta-analysis of six randomized trials found no significant overall effect. Appetite reduction and measured weight loss are not the same endpoint, and this drug is a clear example of the gap.
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.
Blood sugar, the thing it is approved for
Clinical use- Human trialWeek 24 HbA1c down 1.02% and 1.34% on the two doses against 0.17% on placebo, p below 0.0001.
- Human trialHbA1c under 7% reached by 15.7%, 34.7% and 46.6% across placebo and the two doses.
- Human trialA metformin add-on trial across 44 sites gave HbA1c reductions of about 1.15% against placebo.
Weight, where the label and the marketing disagree
tested-and-failed- RegulatoryThe Chinese label states no significant body-weight change against placebo in either pivotal phase 3 trial, and gives no numbers at all.
- ReviewA meta-analysis of six randomized trials in 1,248 people found no significant overall weight effect: mean difference 3.47 kg lower, interval 10.86 lower to 3.92 higher, p=0.36, I-squared 90%.
- No dataThe large kilogram figures come from a 2026 single-center study at 300 and 400 micrograms, above the approved 200 microgram maximum, in people with a body mass index of 50 or above.
Identity, and how it differs from its shelfmates
none- lab-analysisA single synthetic 39-residue modified exendin-4 chain with branched polymer at one engineered site, total mass about 44,200 Da, so roughly nine tenths polymer.
- lab-analysisNot a fusion protein. Efpeglenatide, the other long-acting exendin derivative here, is a three-chain recombinant protein with five disulfide bonds.
- RegulatoryLoxenatide has no separate substance registry record: it is a name field of pegloxenatide rather than a different molecule.
Claims that need their design stated
none- No dataA reported 32% reduction in major cardiovascular events comes from a retrospective real-world cohort with machine-assisted record screening, not a randomized cardiovascular outcomes trial, and carries no hazard ratio, no confidence interval and no event counts.
- No dataThe release reporting it contradicts itself on cohort size, giving over 10,000 in the headline and over 12,000 in the body.
- No dataA February 2026 publication in 269 patients across 16 hospitals had no control group, so it cannot attribute its findings to the drug.
The central error is treating it as a weight-loss drug. It is a GLP-1, so the assumption is understandable, but its own Chinese label states no significant body-weight change against placebo in either pivotal trial, and a meta-analysis of six randomized trials found no significant overall weight effect, with a confidence interval running from 10.86 kg lower to 3.92 kg higher. The second error follows from the first: the impressive kilogram figures in circulation come from a 2026 single-center study using 300 and 400 micrograms in people with a body mass index of 50 or above, and those doses are 1.5 and 2 times the approved 200 microgram maximum. The third is the cardiovascular claim, a 32% reduction in major events that comes from a retrospective real-world cohort rather than a randomized outcomes trial, with no hazard ratio, no interval and no event counts, from a release that contradicts itself on how many people were in it. The fourth is calling it a protein or grouping it with efpeglenatide: this is a synthetic peptide with a polymer attached, while efpeglenatide is a three-chain recombinant fusion protein. Last, two dates get repeated loosely: the approval is May 5, 2019, with the developer's own page giving May 7 in its metadata, and the reimbursement listing is better supported as 2020 than 2019.
The published record
Papers about Pegloxenatide (Fulaimei)
Searched: pegloxenatide, polyethylene glycol loxenatide, PEG-loxenatide, loxenatide, PEX168.
Left out: efpeglenatide (a different long-acting exendin derivative with its own slug. It is a three-chain recombinant FUSION PROTEIN with five disulfide bonds, where this is a single synthetic chain with a polymer attached. The two are routinely grouped as though they were the same strategy); exenatide (the unconjugated parent peptide, with its own slug and a very large literature that is not about this molecule); GLP-1 (the receptor class term, returning tens of thousands of records across the whole drug class); semaglutide (the class weight-loss benchmark, whose literature will swamp a drug whose own label reports no weight effect); Hansoh (a company name spanning a portfolio, including a GLP-1/GIP dual agonist added in this same batch); Fulaimei (the Chinese trade name, which returns commerce pages rather than literature).
38 papers tagged human · 19 not reviews or lab · 12 clinical trial publications
How the compound was given: 6 applied to skin · 18 injected · 10 by mouth or rectal · 22 route not stated in the abstract
Read from each paper's indexing terms and abstract, by rule. A paper that mentions a cream studied a cream, not necessarily the product being sold.
13 registered trials · none with posted results
Furthest stage reached: Approved outside the US, China
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. A preprint and its journal version count once.
At a glance
Four things to know about Pegloxenatide (Fulaimei)
Evidence
Clinical use
Category
Weight loss and metabolic
Common vial
Varies
Half-life
Long enough for weekly dosing; no single published figure located
How much, and do you cycle it?
The range, and whether you take breaks.0.1 or 0.2 mg once weekly, the two approved strengths, once weekly. Continuous weekly dosing FDA label
A chronic diabetes medicine taken indefinitely, titrated upward rather than cycled.
How long does it stay in the body?
The half-life, and where the figure comes from.Long enough for weekly dosing; no single published figure locatedNo figure
Approved for once-weekly use, so the half-life is of the order of days, but no numerical value could be read from a source we could reach. The mechanism is size rather than protein binding: at about 44,200 Da the molecule is too large for kidney filtration. That also makes clearance kidney-dependent, and a single-dose study in renal impairment found lower clearance and a longer half-life.
You can compare this against the whole library to see where it sits.
How is it given?
Dosing context and source notes.Supplied as a finished prescription product rather than a research vial, so no vial draw can be shown and the calculator does not apply. The two approved strengths are 0.1 and 0.2 mg once weekly. Doses of 300 and 400 micrograms appear in a 2026 publication and are above the approved maximum.
How do you store it?
Before mixing, and after.Follow the storage on the product label.
Pegloxenatide (Fulaimei) is supplied as a finished product, so its label sets the storage. Pens, prefilled syringes, implants, tablets and ready-made solutions are used as supplied. Kits that include a powder are mixed just before the dose and usually used straight away, not kept for weeks. Many injectable products go in the fridge and must not be frozen, while others are kept at room temperature, so check the pack or ask the pharmacist.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Using it for weight loss on the assumption that every GLP-1 reduces weight, since its own label reports no significant weight change against placebo in either pivotal trial
- Quoting the large kilogram figures from the 2026 publication, measured at 300 and 400 micrograms, above the approved 200 microgram maximum
- Treating the reported cardiovascular benefit as trial evidence, because it comes from a retrospective real-world cohort rather than a randomized outcomes trial
Stop and get help
- Severe or persistent abdominal pain, a possible sign of pancreatitis in this drug class
- Persistent vomiting with an inability to keep fluids down
- Signs of an allergic reaction, including rash, swelling or difficulty breathing
Common effects
- Nausea and other gastrointestinal effects, as with every GLP-1 receptor agonist.
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Pegloxenatide (Fulaimei) approved?
And where the numbers on this page come from.Not in the United States. Pegloxenatide (Fulaimei) has no FDA approval. It is approved in China.
- Approval statusClinical use
- RouteUnder the skin (subcutaneous injection, once weekly)
- Checked5 November 2026
- Approved outside the USChina.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- Sources
What has happened recently
Approved by China's NMPA on May 5, 2019, held by Jiangsu Hansoh, as a Class 1 chemical drug for adults with type 2 diabetes. The developer's own page contradicts itself on the day, giving May 5 in the body and May 7 in the page metadata. Reimbursement is real but much narrower than usually described: it is a negotiated exclusive listing, and the payment scope requires a body mass index of 25 or above, failure on metformin or other oral agents or insulin, and a first prescription written by a specialist at a tier-2 or higher hospital. That agreement expires on December 31, 2026. The year of inclusion conflicts across official forms, one giving 2019 and another 2020, with contemporaneous press pointing to the catalog announced on December 28, 2020, so 2020 is the better supported date. There is no US approval and no US label: an openFDA query returned nothing while the same query form returned five records for semaglutide as a control, and a DailyMed search returned nothing against nine for the same control. One identity note for anyone searching: loxenatide has no separate substance registry record of its own. It is a name field of pegloxenatide, not a different molecule.
You can compare this against the whole library, or read how to check a seller.
What else is like Pegloxenatide (Fulaimei)?
Others in GLP-1 agonists, side by side.If you're weighing Pegloxenatide (Fulaimei), it's worth reading Pemvidutide, Poterepatide (HDM1005), and RAY1225 (Bilpatide) in the same class.
A weekly GLP-1 whose label says it does not cause weight loss.
- Dose
- 0.1 or 0.2 mg once weekly, the two approved strengths
- How often
- Once weekly
An experimental weekly shot for weight loss and fatty liver.
- Dose
- 1.2 up to 2.4 mg per week (trial doses)
- How often
- Weekly
A dual agonist that stopped gaining above 2 mg.
- Dose
- 0.5 to 4 mg weekly across the phase 2 dose range
- How often
- Once weekly
A fortnightly dual agonist with a topline nobody can place in time.
- Dose
- 3 to 18 mg every 2 weeks across the phase 2 dose range
- How often
- Every 2 weeks
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.
- Semaglutide vs Tirzepatide vs Retatrutide
One receptor, two, or three. Mechanism, trial weight loss, side effects, and real cost.
Sources
- Diabetes, Obesity and Metabolism, pegloxenatide monotherapy in type 2 diabetes(2021)Volume 23, issue 1, pages 116 to 124. The pivotal monotherapy trial behind the Chinese approval. Week 24 HbA1c fell 1.02% on 100 micrograms and 1.34% on 200 micrograms against 0.17% on placebo, p below 0.0001, with HbA1c under 7% reached by 15.7%, 34.7% and 46.6% of each group. Two record problems worth knowing: the registry and the label give 406 randomized where the paper reports 361, unresolved; and the trial's registry entry still reads status unknown, last verified January 2016, for a drug approved in 2019.
- Scientific Reports, systematic review and meta-analysis of pegloxenatide(2023)Volume 13. Six randomized trials, 1,248 participants. The finding that matters most for this page: **no significant overall effect on body weight**, mean difference 3.47 kg lower with a 95% confidence interval from 10.86 lower to 3.92 higher, p=0.36, with very high heterogeneity at an I-squared of 90%. A weight reduction reached significance only in an obese subgroup compared against a metformin control. This is the published counterpart to what the label already says.
- FDA substance registration record for pegloxenatide(2026)UNII BS678C7JWM, CAS 2420483-82-3, international nonproprietary name code 11866. Confirms a single synthetic peptide chain of 39 residues rather than a fusion protein, and total molecular weight around 44,200 Da reflecting the polymer. For comparison in the same registry, exenatide is one unconjugated 39-residue chain and efpeglenatide is a fusion protein of three subunits, 221 plus 221 plus 39 residues, with five disulfide bonds.
- British Journal of Clinical Pharmacology, single-dose pharmacokinetics in renal impairment(2019)Volume 85, issue 12, pages 2714 to 2720, titled a pharmacokinetic study of this drug in subjects with renal impairment. A single 200 microgram dose in reduced kidney function showed lower clearance and a prolonged half-life, with the authors noting that dose adjustment might be required. This matters more for a PEGylated drug than for a short peptide, because the polymer is the reason the molecule depends on the kidney for clearance in the first place.
Beyond these, 60 records are indexed. Browse the records