Plecanatide (Trulance)_Dosage, benefits & legal status
Also known as Trulance, SP-304, Plectide
A daily constipation tablet that works inside the gut and barely reaches the blood.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Plecanatide (Trulance)?
Plain language first. The technical label stays, but it never stands alone.Overview
It draws water into the bowel so stools are softer and come more often. In 12-week trials about 1 in 5 people on it met the strict responder definition against 1 in 10 to 1 in 8 on placebo. The FDA approved it in 2017 for chronic constipation and in 2018 for IBS with constipation.
Plecanatide is a 16-residue peptide identical to human uroguanylin except for one swapped residue, held in shape by two disulfide bridges. It switches on guanylate cyclase-C on the inner lining of the intestine, the same target as linaclotide, and works almost entirely inside the gut. Synergy Pharmaceuticals developed it; Salix, part of Bausch Health, now sells it.
What it's used for
A prescription tablet for adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.
How does Plecanatide (Trulance) work?
What it does in the body, and where.Plecanatide copies uroguanylin, a hormone the small intestine releases to control its own fluid balance.
- 01The gut receptorIt binds guanylate cyclase-C on the cells lining the intestine, raising cGMP inside and outside them.
- 02Water incGMP opens the CFTR channel, so chloride and bicarbonate flow into the bowel and water follows. Stools soften and move faster.
- 03Staying localBlood levels were mostly too low to measure. In the gut it loses its last leucine to form an active metabolite, and both are broken down to amino acids.
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.
Chronic idiopathic constipation
FDA-approved- Human trialTwo trials with 2,804 adults: durable responders 21.0% and 20.1% on 3 mg against 10.2% and 12.8% on placebo.
- Human trialComplete bowel movements rose by 2.5 a week against 1.2 in the first trial.
IBS with constipation
FDA-approved- Human trialTwo trials with 2,189 adults: overall responders 30.2% and 21.5% against 17.8% and 14.2%.
- Human trialAbdominal pain responders 41% against 32% and 33% against 23%.
Against linaclotide
FDA-approved- ReviewThere is no head-to-head trial. A meta-analysis found no significant difference in effect or diarrhoea.
- No dataIts 'pH-sensitive' advantage rests on computer modelling and company claims, not on clinical data.
'Less diarrhoea than linaclotide' is not supported: there is no head-to-head trial, and a meta-analysis found no significant difference. The 'pH-sensitive like natural uroguanylin' claim comes from computer modelling and Synergy's marketing. It is contraindicated under 6 and to be avoided from 6 to 17, not 'contraindicated under 18'. The IBS approval was on 24 January 2018; the press release is dated the 25th. Label and paper percentages differ slightly by analysis set (21% against 13% in the label, 20.1% against 12.8% in the paper). No plasma half-life can be calculated, so any quoted figure is wrong. No generic is approved; 'generic Trulance' sold online is illegal.
The published record
Papers and trials about Plecanatide (Trulance)
90 papers tagged human · 38 not reviews or lab · 12 clinical trial publications
15 registered trials · 11 with posted results
Furthest stage reached: Approved in 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.
At a glance
Four things to know about Plecanatide (Trulance)
Evidence
FDA-approved
Category
Healing and recovery
Common vial
Varies
Half-life
Not measurable (stays in the gut)
How much, and do you cycle it?
The range, and whether you take breaks.3 mg once daily (label), once daily, with or without food. Continuous, set by the prescription FDA label
Taken daily for as long as needed; the trials lasted 12 weeks, with open-label use beyond that.
How long does it stay in the body?
The half-life, and where the figure comes from.Not measurable (stays in the gut)FDA label
After a 3 mg dose most blood samples were below the limit of measurement, so no half-life, peak or AUC could be calculated. Even at 9 mg it was detected in only one of 24 fasted people. It acts and is broken down inside the gut.
Source: Trulance prescribing information section 12.3
You can compare this against the whole library to see where it sits.
What does it cost?
Typical dose and cost, in plain numbers.Plecanatide (Trulance) is not injected
It is taken by mouth (tablet). One 3 mg tablet a day for either condition, with or without food. For swallowing problems the tablet can be crushed into a teaspoon of apple sauce, dispersed in about 30 mL of water, or given down a feeding tube. Skip a missed dose; never double. A 6 mg dose added no benefit and more side effects. The label gives no kidney or liver dose changes; almost none is absorbed. A tablet, so the vial calculator does not apply.
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 Plecanatide (Trulance) 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: 31% charged residues, 56% 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
- Children under 6: the label forbids it after single doses killed young mice through dehydration
- Ages 6 to 17: the label says to avoid it
- Known or suspected bowel blockage
Stop and get help
- Severe or watery diarrhoea, especially with dizziness, thirst or little urine
- Blood in the stool or black stools
- Hives, itching or a spreading rash
Common effects
- Diarrhoea in 5% against 1% on placebo in chronic constipation, and 4.3% against 1% in IBS
- Severe diarrhoea in 0.6% against 0.3% (constipation) and 1% against 0.1% (IBS)
- Stopping because of diarrhoea in 2% against 0.5%
- Sinusitis, colds, bloating, wind and raised liver tests, each in under 2%
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Plecanatide (Trulance) approved?
And where the numbers on this page come from.Yes. Plecanatide (Trulance) is FDA approved and available on prescription in the United States. It is also approved in Canada.
- Approval statusFDA-approved
- RouteBy mouth (tablet)
- Checked13 October 2026
- Approved outside the USCanada: Authorised in Canada for IBS with constipation (10 October 2019) and chronic idiopathic constipation (24 December 2024). An Indian expert committee recommended a local version (Plectide) in April 2023. Also approved in the US.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.
- SourcesTrulance prescribing information (4/2021)Trulance on DailyMed (revised 3/2024)Drugs@FDA, NDA 208745FDA GSRS substance record, plecanatide (UNII 7IK8Z952OK)Miner PB et al., American Journal of Gastroenterology 2017;112:613-621DeMicco M et al., Therapeutic Advances in Gastroenterology 2017;10:837-851Brenner DM et al., American Journal of Gastroenterology 2018;113:735-745Shah ED et al., American Journal of Gastroenterology 2018;113:329-338Brancale A et al., Pharmacology Research & Perspectives 2017;5:e00295Health Canada summary basis of decision, Trulance
What has happened recently
FDA-approved on 19 January 2017 for chronic idiopathic constipation in adults (NDA 208745) and on 24 January 2018 for IBS with constipation. The label carries a boxed warning: it is contraindicated under 6 and to be avoided from 6 to 17, after fatal dehydration in young mice. Bausch Health bought Synergy's assets, including Trulance, out of bankruptcy for about $195 million in March 2019; Salix holds the NDA. No generic is approved: Mylan settled patent litigation in 2025 and MSN in 2026, with confidential entry dates, and the last listed patent runs to 2034. Approved in Canada (IBS with constipation 2019, chronic constipation 2024); an Indian expert committee recommended a local version in 2023. No EU, UK or Japanese approval was found.
You can compare this against the whole library, or read how to check a seller.
What else is like Plecanatide (Trulance)?
Others in Healing and recovery, side by side.If you're weighing Plecanatide (Trulance), it's worth reading Redasemtide, Retinalamin, and Sigumir in the same class.
A daily constipation tablet that works inside the gut and barely reaches the blood.
- Dose
- 3 mg once daily (label)
- How often
- Once daily, with or without food
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- Dose
- 0.75 to 1.5 mg/kg daily for 5 days, or weekly (trial doses)
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- Dose
- 5 up to 10 mg per day
- How often
- Daily, in 10-day courses
A bioregulator for bone, joint, and cartilage health, with thin evidence.
- Dose
- Varies (course-based)
- How often
- Courses
Guides for this compound
- 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.
Sources
- Trulance prescribing information (4/2021)(2021)3 mg once daily; boxed warning on paediatric dehydration; plasma levels mostly unmeasurable, so no half-life; disulfides at 4-12 and 7-15; diarrhoea 5% against 1%.
- Trulance on DailyMed (revised 3/2024)(2024)Responder rates with confidence intervals: 21% against 10% and 21% against 13% (constipation); 30% against 18% and 21% against 14% (IBS).
- Drugs@FDA, NDA 208745(2026)Approved 19 January 2017; IBS with constipation 24 January 2018; Salix is the holder.
- FDA GSRS substance record, plecanatide (UNII 7IK8Z952OK)(2026)16 residues, NDECELCVNVACTGCL, disulfides 4-12 and 7-15; CAS 467426-54-6.
- Miner PB et al., American Journal of Gastroenterology 2017;112:613-621(2017)1,394 adults with chronic constipation: durable responders 21.0% on 3 mg against 10.2% on placebo.
- DeMicco M et al., Therapeutic Advances in Gastroenterology 2017;10:837-851(2017)Second constipation trial, 1,410 randomised: 20.1% against 12.8%.
- Brenner DM et al., American Journal of Gastroenterology 2018;113:735-745(2018)Two IBS trials, 2,189 randomised: overall responders 30.2% and 21.5% against 17.8% and 14.2%; diarrhoea 4.3% against 1.0%.
- Shah ED et al., American Journal of Gastroenterology 2018;113:329-338(2018)Meta-analysis: no significant difference from linaclotide in efficacy, diarrhoea or stopping for diarrhoea.
- Brancale A et al., Pharmacology Research & Perspectives 2017;5:e00295(2017)Computer modelling: plecanatide's most active shapes occur at pH 5, the pH of the upper small intestine. No binding measurements.
- Health Canada summary basis of decision, Trulance(2019)Authorised in Canada on 10 October 2019 for IBS with constipation in adults.
Beyond these, 124 records are indexed. Browse the records