Visepegenatide (PB-119, Paidakang)_Dosage, benefits & legal status
Also known as PB-119, Paidakang, 派达康, 派達康, PEGylated exenatide injection, visepegenatide injection
Exenatide with one serine swapped for a cysteine, and a polymer tied to it.
What is Visepegenatide (PB-119, Paidakang)?
Plain language first. The technical label stays, but it never stands alone.Overview
This is a weekly GLP-1 injection for type 2 diabetes, approved in China in November 2025 and not available in the United States. It is built from exenatide, the oldest drug in this class, by changing a single building block at the end of the chain from serine to cysteine, then tying a polyethylene glycol chain onto that cysteine. The polymer is what makes a twice-daily drug into a weekly one. Two things are worth knowing before assuming this behaves like the GLP-1 drugs people talk about for weight loss. First, it is approved for blood sugar, not weight, and the weight numbers in its developer's own disclosure documents sit under a kilogram, with one figure in the table showing a small gain. Second, most of the money disclosed so far is not patients buying it. A distributor took over selling it in March 2026 and has paid the developer milestone and royalty money; prescriptions had started at several hospitals as of the mid-2026 report, but no figure for what patients actually bought has been published.
Visepegenatide is a PEGylated exenatide analog and once-weekly GLP-1 receptor agonist, approved by China's National Medical Products Administration in November 2025 for type 2 diabetes as monotherapy and with metformin, and sold there as Paidakang. The peptide is 39 residues and differs from exenatide at exactly one position: the C-terminal serine is replaced by a cysteine, and the polymer is attached at that cysteine. It is given at 150 mcg under the skin once weekly with no dose titration, the feature its developer leads with. It is not approved anywhere for obesity, where it is in phase 1/2 in China, and it is not approved in the United States.
What it's used for
Approved in China for adults with type 2 diabetes, both as a first-line monotherapy and added to metformin. Obesity is a separate program in phase 1/2 in China and is not an approved use. Cardiovascular outcome, basal insulin combination and SGLT-2 combination studies are at the investigational new drug stage in China.
How does Visepegenatide (PB-119, Paidakang) work?
What it does in the body, and where.Exenatide is a 39-residue peptide from Gila monster venom that activates the GLP-1 receptor. Its problem has always been that it disappears fast. The fix here is a single engineered attachment point.
- 01Serine 39 becomes cysteineThat substitution supplies a free thiol group nothing else in the chain has. It does no receptor work at all.
- 02A polymer bonds to that cysteine and nowhere elseSite-specific attachment rather than polymer scattered across the molecule. That is the difference between a defined drug substance and a mixture.
- 03Kidney clearance slows downThe polymer makes the molecule too large to filter quickly, stretching a twice-daily drug to once weekly.
- 04The peptide still does its original jobGLP-1 receptor activation prompts insulin release when glucose is high and slows gastric emptying.
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.
What one residue buys
Research only- Lab studySet against this site's exenatide sequence, visepegenatide's 39-residue chain differs at position 39 and nowhere else: serine becomes cysteine. The substitution has no receptor purpose; it exists so a polymer has a single defined place to attach.
- Lab studyPegloxenatide, the other PEGylated exenatide approved in China and already on this site, uses the same trick at the same position but carries four changes from the native venom peptide rather than one. Two drugs, the same anchor point, different amounts of engineering around it.
The two phase 3 trials
Clinical use- Human trialPB119-301, drug-naive monotherapy, 273 adults randomized 137 to 136. Week 24 HbA1c 0.73 points below placebo, 95% CI 0.96 to 0.50, p below 0.001. HbA1c below 7% in 50.4% against 14.2%. Week 4 reduction already 0.82 points. Registered as NCT04504370, completed, with a primary completion date of March 30, 2022.
- Human trialPB119-302, added to metformin, 620 adults enrolled. Week 24 HbA1c 0.57 points below placebo, 95% CI 0.71 to 0.43. HbA1c below 7% in 40.5% against 17.9%, and below 6.5% in 21.1% against 6.1%. The registry number for this trial was not established from the sources checked here.
- No dataWeight change is small and the developer's own table is ambiguous about it: values for the two trials range from a 0.69 kg loss to a 0.52 kg gain, with column labels that do not resolve the 24-week against 52-week mapping. The document describes this as remarkable weight loss.
- ReviewPhase 2 tested 75, 150 and 200 mcg weekly against placebo for 12 weeks in 251 treatment-naive Chinese patients and was published in Diabetologia in March 2021. A correction was later issued to that paper, softening a sentence that had been edited into a definite claim of superiority over oral antidiabetic drugs.
Registry lag, and what the money represents
Clinical use- No dataThe phase 3 registry record was last updated July 28, 2023, more than two years before the drug was approved, and lists a single study site. The approval, the licensing deal and the launch are all absent from it. Anyone checking this compound in the registry alone would conclude nothing had happened since 2023.
- RegulatoryAn exclusive mainland China commercialization agreement was signed in March 2026, with the distributor responsible for selling the product and an aggregate sales target stated as over RMB 10 billion. A first royalty payment of HK$61 million has been received and the conditions for a second of HK$49 million were met after the mid-2026 period end.
- No dataThose payments come from the licensee, not from patients. The developer's mid-2026 summary records prescriptions issued at multiple institutions after the period end and gives no figure for units or revenue from them. Distributor money is a bet on demand, not a measurement of it.
Treating this as a weight-loss drug. It is a GLP-1 agonist, and that term is now shorthand for weight loss, but it is approved for blood sugar only and its phase 3 weight numbers are under a kilogram. The second misreading is commercial: the HK$61 million and HK$49 million figures are payments from the distributor that licensed the drug, not revenue from patients, and no patient-level sales figure has been published. A third is confusing the two phase 3 trials, whose headline HbA1c differences are 0.73 points (drug-naive, 273 patients) and 0.57 points (metformin add-on, 620 patients); public summaries of these trials cross the two sets of numbers, and at least one database page carries one trial's patient counts beside the other trial's results.
The published record
Papers about Visepegenatide (PB-119, Paidakang) · this compound only
Searched: visepegenatide, PB-119, Paidakang, PEGylated exenatide.
Left out: pegloxenatide (THE critical rejection. The OTHER PEGylated exenatide approved in China, already on this site, using the SAME cysteine-39 polymer anchor. Four changes from the native peptide against this drug's one. A query that catches both will merge two approved Chinese GLP-1 drugs into one record); exenatide (the PARENT molecule, on this site, and identical to this drug at 38 of 39 positions. Any sequence or mechanism search returns it, and its twice-daily and weekly formulations have their own dosing that must not migrate here); exendin-4 (the venom peptide exenatide is derived from, with a large pharmacology literature); efpeglenatide (another long-acting exenatide-family agonist on this site, with a cardiovascular outcome trial. Easily substituted in comparisons); lixisenatide (exenatide-derived and on this site. Same family, different molecule); PEGylation (the chemistry term, spanning every pegylated biologic there is); GLP-1 receptor agonist (the class term, the largest literature on this site); PegBio (the developer, whose pipeline includes several other candidates at the investigational application stage); Tenry Pharmaceutical (the mainland China commercialization licensee, a distributor with an unrelated portfolio); type 2 diabetes (the indication, far too broad); Rani Therapeutics (an unrelated US company that signed an oral-delivery research collaboration with the developer in July 2026, surfaced during research and belonging to neither card).
3 papers tagged human · 3 not reviews or lab · 3 clinical trial publications
How the compound was given: 9 injected · 3 by mouth or rectal · 3 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.
Furthest stage reached: Approved outside the US
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 Visepegenatide (PB-119, Paidakang)
Evidence
Clinical use
Category
Weight loss and metabolic
Common vial
Varies
Half-life
Long enough for weekly dosing; no published figure found
How much, and do you cycle it?
The range, and whether you take breaks.150 mcg once weekly, no titration, once weekly. Weekly and ongoing, with no planned stop Trial dose
Type 2 diabetes treatment is continuous. The phase 3 ran 24 weeks double-blind followed by a 28-week extension, for 52 weeks of uninterrupted weekly dosing.
Long enough for weekly dosing; no published figure foundNo figure
No half-life figure appears in the sources checked here. The weekly interval and the polymer attachment point are documented; the pharmacokinetic parameters are not in the company filings or the registry record, and there is no FDA label because the drug is not approved in the United States.
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.Follow the storage on the product label.
Visepegenatide (PB-119, Paidakang) 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.Solubility, computed: 28% charged residues, 41% 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
- Any assumption of US availability: this drug is approved in China and is not an FDA-approved product
- Any expectation of meaningful weight loss, a claim its own phase 3 tables do not support
- Treating it as interchangeable with pegloxenatide, the other PEGylated exenatide approved in China. That is a different molecule with four changes from the native peptide rather than one
Stop and get help
- Severe or persistent abdominal pain, especially with vomiting. That is the presentation that raises pancreatitis as a question in this drug class
- Signs of a serious allergic reaction after an injection
- Any decision to start or stop belongs with the prescribing physician, in practice a physician in China
Common effects
- Nausea, diarrhea and vomiting, more often than on placebo but at single-digit to low double-digit patient counts in trials of 273 and 620 people
- Raised blood lipase without symptoms
- Raised uric acid, seen in both arms and more often on drug in the drug-naive trial
- Very little weight change in either direction
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Visepegenatide (PB-119, Paidakang) approved?
And where the numbers on this page come from.Not approved, but legal to obtain. Visepegenatide (PB-119, Paidakang) has no FDA approval, and it can be prescribed or prepared by a compounding pharmacy in the United States.
- Approval statusClinical use
- RouteUnder the skin, once weekly
- Checked11 November 2026
- Approved outside the USThis does not change the United States position above.
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA Global Substance Registration System protein record for visepegenatide, UNII NX5QFO4QGSPegBio listing document, PB-119 development and phase III resultsPegBio annual report, marketing approval from the NMPA in November 2025PegBio voluntary announcement, exclusive mainland China commercialization collaboration, March 2026PegBio announcement on use of proceeds, September 2026, confirming the commercialization stagePegBio pipeline page, approval and launch status by indicationClinicalTrials.gov phase 3 record NCT04504370Phase II study of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes, Diabetologia 2021, DOI 10.1007/s00125-021-05392-9
What has happened recently
Approved by China's National Medical Products Administration in November 2025, after the application was accepted in September 2023 and spent time in a supplementary review stage from May 2025. Two dates circulate for the approval: the developer's own annual report states approval for marketing in China on November 14, 2025, while a commercial drug database records a first approval date of November 12, 2025. The company filing is the stronger of the two. Commercialization in mainland China was licensed to a distributor in March 2026 under an agreement with an aggregate sales target stated as over RMB 10 billion. The developer has received a first royalty payment of HK$61 million and reported that the conditions for a second payment of HK$49 million were met after the mid-2026 reporting period. Not approved in the United States, the European Union or any other jurisdiction on the record checked here.
You can compare this against the whole library, or read how to check a seller.
What else is like Visepegenatide (PB-119, Paidakang)?
Others in GLP-1 agonists, side by side.If you're weighing Visepegenatide (PB-119, Paidakang), it's worth reading VK2735, Zabopegdutide (DD01), and Zovaglutide (ZT-002) in the same class.
Exenatide with one serine swapped for a cysteine, and a polymer tied to it.
- Dose
- 150 mcg once weekly, no titration
- How often
- Once weekly
An experimental weight-loss compound in the tirzepatide family, as a shot or pill.
- Dose
- 2.5 up to 15 mg per week (start low, increase slowly)
- How often
- Weekly
Nearly the same peptide as efinopegdutide, carried on a large PEG instead of an antibody fragment. In a 67-person phase 2, 76% on the drug cut liver fat by at least 30% in 12 weeks, against 12% on placebo.
- Dose
- 20 mg weekly for 2 weeks, then 40 mg weekly (phase 2 trial)
- How often
- Weekly
An experimental once-a-month weight-loss shot.
- Dose
- 80 up to 160 mg per month (trial doses)
- How often
- Monthly
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
- FDA Global Substance Registration System protein record for visepegenatide, UNII NX5QFO4QGS
- PegBio listing document, PB-119 development and phase III results
- PegBio annual report, marketing approval from the NMPA in November 2025
- PegBio voluntary announcement, exclusive mainland China commercialization collaboration, March 2026
- PegBio announcement on use of proceeds, September 2026, confirming the commercialization stage
- PegBio pipeline page, approval and launch status by indication
- ClinicalTrials.gov phase 3 record NCT04504370
- Phase II study of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes, Diabetologia 2021, DOI 10.1007/s00125-021-05392-9
Beyond these, 13 records are indexed for this compound. Browse the records