Canvuparatide_Dosage, benefits & legal status
Also known as MBX 2109, MBX-2109, canvuparatide hydrochloride
Parathyroid hormone fitted with fatty tails and a self-releasing cap so one injection lasts a week. Phase 3 started in August 2026.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Canvuparatide?
Plain language first. The technical label stays, but it never stands alone.Overview
People with hypoparathyroidism cannot make enough parathyroid hormone, so blood calcium falls and they live on calcium and active vitamin D tablets. In a 64-person phase 2, 63% on weekly canvuparatide had normal calcium without active vitamin D at 12 weeks, against 31% on placebo. A 160-person phase 3 began in August 2026. It is not approved anywhere.
Canvuparatide (MBX 2109) is a prodrug of parathyroid hormone (1-32) from MBX Biosciences, the Indiana company co-founded by peptide chemist Richard DiMarchi. An extra D-lysine and sarcosine pair at the front keeps it inactive until that pair falls off by itself in the body, and two fatty-acid chains make it ride on albumin, so the active hormone lasts about 8 days.
What it's used for
An experimental once-weekly injection to replace missing parathyroid hormone in chronic hypoparathyroidism.
How does Canvuparatide work?
What it does in the body, and where.Canvuparatide is parathyroid hormone built to switch itself on slowly after injection.
- 01The missing hormoneParathyroid hormone tells the kidneys to keep calcium and make active vitamin D, and keeps bone turnover going. Without it, blood calcium falls and urine calcium rises; tablets raise calcium but do not replace the hormone.
- 02A self-releasing capA D-lysine and sarcosine pair on the front blocks the hormone's active end. In the body that pair cyclises and drops off by itself, with no enzyme needed, releasing active parathyroid hormone (1-32).
- 03Riding on albuminFatty-acid chains bind albumin in the blood. The active form keeps one and lasts 184 to 213 hours, so levels vary little between weekly doses.
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 2 Avail
Investigational- Human trial64 adults: responders 63% against 31% on placebo at 12 weeks; by starting dose, 50%, 69% and 69%, with only the 800 mcg arm significant on its own.
- Human trialFree of active vitamin D 98% against 63%; calcium in the normal range 81% against 44%.
- No dataUrine calcium fell on placebo too, so the drug's own effect on it is unclear.
One year on
Investigational- Human observationIn the open-label extension, responders were 79% at 6 months and 57% at one year; MBX calls this sustained.
Healthy volunteers
Investigational- human-earlyFour weekly doses in 40 healthy adults: calcium rose with dose, the body's own parathyroid hormone was suppressed from 400 mcg, and the active form lasted 7.7 to 8.9 days.
It is built on parathyroid hormone (1-32), not the 1-34 fragment used in teriparatide, and has 35 residues in all. There are two fatty-acid chains, and the part that falls off is the D-lysine and sarcosine cap, by itself rather than by an enzyme; one fatty chain stays on the active hormone. 'Sustained benefit' covers responder rates of 63% at 12 weeks, 79% at 6 months and 57% at one year. The phase 2 p-value is given as 0.042, 0.0427 and 0.043, the same result rounded. The FDA substance database's molecular weight of about 3,856 is the bare peptide backbone only. Some databases list it for hyperparathyroidism; it is for hypoparathyroidism. No weekly parathyroid hormone is approved yet.
The published record
Papers and trials about Canvuparatide
7 papers tagged human · 2 not reviews or lab · 2 clinical trial publications
5 registered trials · none with posted results
Furthest stage reached: Phase 3, oPTimize (NCT07699471), recruiting since August 2026
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 Canvuparatide
Evidence
Investigational
Category
Healing and recovery
Common vial
Varies
Half-life
About 8 days (active hormone)
How much, and do you cycle it?
The range, and whether you take breaks.400 to 1,600 mcg once weekly (phase 3 range; 600 mcg for the first 4 weeks), once weekly. Continuous, weekly Trial dose
Meant as lifelong hormone replacement; the phase 3 runs 26 weeks double-blind and then 78 weeks open-label.
About 8 days (active hormone)Human study
The released active form lasts 184 to 213 hours; the injected prodrug itself 79 to 95 hours. Peak levels come 2 to 3 days after a dose.
Source: Carney P et al., JCEM 2025 (phase 1, healthy adults)
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 Canvuparatide 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: 37% charged residues, 34% 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
- Raised bone-tumour risk (Paget's disease of bone, past radiation to the skeleton): approved parathyroid hormone drugs carry an osteosarcoma caution from rat studies, not yet established for canvuparatide
- Pregnancy or breastfeeding, with no data
- Use outside a trial: it is not approved anywhere
Stop and get help
- Nausea, vomiting, confusion, constipation, extreme thirst or weakness, signs of high blood calcium
- Tingling around the mouth or in the fingers, or muscle cramps, signs of low blood calcium
Common effects
- Headache in 20.8% against 6.3% on placebo over 12 weeks
- High blood calcium in 18.8% against 6.3%, and 31% in the group that started on 800 mcg
- Joint pain in 14.6% against none, and nausea in 12.5% against 6.3%
- Injection-site reactions in 18.8% against 12.5%
- No treatment-related serious adverse events or discontinuations in the phase 2
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Canvuparatide approved?
And where the numbers on this page come from.No. Canvuparatide 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.
- SourcesCarney P et al., Journal of Clinical Endocrinology & Metabolism 2025;110:940-950FDA GSRS substance record, canvuparatide (UNII 7YT49ZX2QZ)MBX Biosciences, Avail phase 2 topline (SEC 8-K exhibit 99.1, Sep 2025)MBX Biosciences, Avail topline presentation (SEC exhibit 99.2)Cleveland Clinic Journal of Medicine, ENDO 2026 reportMBX Biosciences, one-year extension data (12 Jun 2026)MBX Biosciences, first patient dosed in oPTimize (27 Aug 2026)ClinicalTrials.gov, oPTimize (NCT07699471)FDA Drug Trials Snapshot, Yorvipath (palopegteriparatide)
What has happened recently
Not approved anywhere. The pivotal oPTimize phase 3 (NCT07699471, about 160 adults, randomised 3:1 against placebo) dosed its first patient in August 2026, with primary completion estimated in January 2028. The FDA granted orphan drug designation for hypoparathyroidism in July 2022, and the EU has also granted orphan designation. Canvuparatide is a proposed INN (WHO list 131). The approved alternatives are daily: palopegteriparatide (Yorvipath, FDA 2024); Natpara was discontinued worldwide at the end of 2024. The phase 2 results have been presented but not yet published in a journal.
You can compare this against the whole library, or read how to check a seller.
What else is like Canvuparatide?
Others in Healing and recovery, side by side.If you're weighing Canvuparatide, it's worth reading Cerluten, Linaclotide (Linzess), and Nerinetide (NA-1) in the same class.
Parathyroid hormone fitted with fatty tails and a self-releasing cap so one injection lasts a week. Phase 3 started in August 2026.
- Dose
- 400 to 1,600 mcg once weekly (phase 3 range; 600 mcg for the first 4 weeks)
- How often
- Once weekly
A bioregulator for brain and nerve support, with thin evidence.
- Dose
- Varies (course-based)
- How often
- Courses
An approved oral peptide for constipation that works in the gut and barely reaches the blood.
- Dose
- 72, 145 or 290 mcg once daily (label)
- How often
- Once daily
A 20-residue peptide built to stop nerve cells dying during a stroke. Over 2,400 patients later, the main results are neutral.
- Dose
- 2.6 mg/kg once, up to 270 mg (trials)
- How often
- A single dose
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
- Carney P et al., Journal of Clinical Endocrinology & Metabolism 2025;110:940-950(2025)Phase 1 in healthy adults: prodrug half-life 79 to 95 hours, active peptide 184 to 213 hours; structure is parathyroid hormone (1-32) with a D-Lys-Sar cap and two C18 fatty diacid chains.
- FDA GSRS substance record, canvuparatide (UNII 7YT49ZX2QZ)(2026)Proposed INN (list 131); CAS 2925554-87-4; parathyroid hormone (1-32) core with two modified sites.
- MBX Biosciences, Avail phase 2 topline (SEC 8-K exhibit 99.1, Sep 2025)(2025)64 adults, 12 weeks: 63% responders on canvuparatide against 31% on placebo (p=0.042).
- MBX Biosciences, Avail topline presentation (SEC exhibit 99.2)(2025)Normal calcium 81% against 44%; free of active vitamin D 98% against 63%. Side effects: headache 20.8% against 6.3%, high calcium 18.8% against 6.3%.
- Cleveland Clinic Journal of Medicine, ENDO 2026 report(2026)Phase 2 details as presented at ENDO 2026: urine calcium, bone markers and anti-drug antibodies.
- MBX Biosciences, one-year extension data (12 Jun 2026)(2026)57% (31 of 54 evaluable) were responders at one year in the open-label extension; no new safety signals. The 79% at 6 months was reported in September 2025.
- MBX Biosciences, first patient dosed in oPTimize (27 Aug 2026)(2026)Phase 3 design: about 160 adults, weekly dosing from 600 up to 1,600 mcg; FDA and EU orphan designations.
- ClinicalTrials.gov, oPTimize (NCT07699471)(2026)Started 26 August 2026; primary endpoint at week 26; primary completion estimated January 2028.
- FDA Drug Trials Snapshot, Yorvipath (palopegteriparatide)(2024)The approved daily comparator: FDA approval 9 August 2024.
Beyond these, 9 records are indexed. Browse the records