What is plecanatide powder used for?

Plecanatide powder (CAS No. 467426-54-6) is a synthetic guanylate cyclase-C (GC-C) agonist peptide used primarily in gastrointestinal research and pharmaceutical development. In clinical medicine, it addresses chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) by stimulating intestinal fluid secretion and accelerating bowel transit. For B2B procurement clients—pharmaceutical companies, CRO/CDMO organizations, and research institutions—this active pharmaceutical ingredient represents a well-characterized research tool and drug development candidate with a 99% assay purity and verified HPLC data backing its quality.

Plecanatide powder

Understanding Plecanatide Powder: Uses and Benefits

Primary Therapeutic Applications

Plecanatide is allowed by the FDA to treat two conditions: IBS-C and CIC. In the United States, these are some of the most common functional gut diseases. Together, they affect about 35 million people. In its role as an API, it provides pharmaceutical formulators with a clinically proven molecule to work with. This is especially helpful when creating prescription gastrointestinal therapies or doing studies that compare different drugs.

Research and Drug Development Value

In addition to being used in direct manufacturing, research-grade plecanatide powder is used for studies of gut movement, the development of peptide drugs, and the study of how constipation works. Laboratories that get this compound have access to a structurally defined 17-amino acid peptide (Asp-Glu-Cys-Cys-Glu-Tyr-Cys-Cys-Asn-Pro-Ala-Cys-Cys-Tyr-Gly-Cys-Cys-OH) with four disulfide bonds that is very similar to the hormone uroguanylin found in the body.

Quality Specifications at a Glance

  • Purity (HPLC): ≥98.0%; single impurity ≤2.0%
  • Peptide content: About 80% of it is made up of peptides and 10% of it is water.
  • Acetate content: 5.0% to 12.0%; looks like white powder that has been frozen
  • Molecular formula: C₆₃H₉₃N₁₅O₂₄S₄; molecular weight: 1584.77 g/mol.

These requirements give QA managers and R&D engineers peace of mind that every batch meets research-grade standards before it is used in a preparation or a pilot study.

How Plecanatide Powder Works: Mechanism of Action

The GC-C Receptor Pathway

Plecanatide binds to the guanylate cyclase-C receptor on intestine epithelial cells only. This binding turns GTP into cyclic GMP inside cells, which turns on the cystic fibrosis transmembrane conductance regulator (CFTR). This causes more chloride and bicarbonate ions to be released into the intestine, which pulls water in and makes stool softer.

pH-Sensitive Activation

One way that plecanatide powder is different from linaclotide in how it works is that it is more sensitive to pH. Plecanatide works best in the slightly acidic environment of the proximal small intestine. This means that it works most effectively where it is needed. This feature stops unnecessary stimulation further down the digestive system, which means that loose stools happen less often than with older GC-C agonists.

Minimal Systemic Absorption

There is a low chance that plecanatide will affect organs other than the one it is meant to treat because it only works locally and is not taken very well into the bloodstream. Because it only works in one area, it is safer for the body than osmotic laxatives or secretagogues, which affect the whole body. This is an important thing to keep in mind when putting it in a product portfolio.

Dosage, Safety, and Side Effects: What Procurement Clients Need to Know?

Standard Dosing Reference

The FDA-approved clinical dose of plecanatide for adults with both CIC and IBS-C is 3 mg taken by mouth once a day. This reference point sets your formulation goal for procurement teams that are making generic formulations or doing bioequivalence studies. Patients younger than six years old should not use it because they could become seriously dehydrated.

Tolerability and Side Effect Profile

The most common side effect in two Phase III clinical trials was diarrhea, which happened to about 5% of patients who were given 3 mg and only 1% of patients who were given a placebo. Serious side effects were very rare and did not differ much from the rates of placebo. For pharmaceutical clients, this good safety profile supports regulatory submissions and product labeling.

Storage and Handling Requirements

Paying attention to storage conditions is important for keeping the quality of a product from the time it is bought until it is used. Plecanatide powder should be kept in a container that is tightly closed and doesn't get wet at -20°C. Each order from Xi'an Yihui is sent in a separate, sealed bag (1g/bag, 100g/bag, or 1kg/bag), along with a certificate of authenticity (COA). This way, when your quality team receives each shipment, they can check it against the specifications.

Comparing Plecanatide Powder with Alternative Treatments

Plecanatide vs. Linaclotide

Both work on GC-C and have been approved by the FDA for both CIC and IBS-C. Linaclotide is a peptide made up of 14 amino acids, while plecanatide powder is made up of 17 amino acids and is structurally similar to human uroguanylin. The pH-dependent activation profile of plecanatide leads to a lower recorded rate of diarrhea (about 5% vs. 20% for linaclotide at its 290 mcg dose in studies), which is an important way for formulators to tell this product apart from others.

Plecanatide vs. Lubiprostone and Traditional Laxatives

Lubiprostone works by activating chloride channel-2 receptors, which is a completely different process. It is linked to sickness as a main side effect. Stimulant laxatives like bisacodyl work on nerve ends in a general way and can make you dependent on them for a long time. Off-the-shelf fiber products help with size, but they don't help with secretions specifically. The specific activity of plecanatide's receptors provides a more physiological approach to regulating bowel movements, which is a selling point for drug companies looking to make unique product claims.

Procurement Positioning Summary

R&D engineers need to know about these differences when they are choosing the best API for their pipeline. The clinical profile of plecanatide can help formulators tell a different story in regulatory submissions and market positioning papers, which is a benefit that goes beyond the cost of the raw materials.

Procuring Plecanatide Powder: Supplier Selection and Buying Guide

Key Criteria for Supplier Qualification

It takes a lot of work to find research-grade or API-grade peptides. Before you place an order with a plecanatide powder seller, make sure you check the following:

  • Quality proof: COA, MSDS, and HPLC test reports proving purity ≥98.0%
  • Certifications: ISO certification and following GMP production standards
  • Custom synthesis capability: If a client needs changed patterns or larger batches, make sure the manufacturer's synthesis platform can handle it.
  • Traceability: Records for each batch for regulatory filings (DMF support when needed)

These checkpoints keep your supply chain safe from quality problems that could cause clinical timelines to slip or regulatory submissions to be tainted.

Packaging and Logistics Planning

Xi'an Yihui has three normal package sizes: 1g, 100g, and 1kg bags. These sizes are good for a wide range of tasks, from early stage lab work to pilot-scale production runs. All of the items are in stock and ready to be sent out right away. Export paperwork and customs reports are given to make sure that delivery to the US and other markets goes smoothly across borders.

Minimum Order and Pricing Considerations

The lowest amount that can be ordered is 1g, which makes it easy for research teams doing pilot studies to get started. Xi'an Yihui is a useful partner whether you are running a research program or getting ready for scale-up buying because their prices go down as you buy more. Get in touch with the sales team directly to get quotes based on volume and to check wait times.

Conclusion

Plecanatide powder is a well-studied GC-C agonist peptide that has been shown to effectively treat both CIC and IBS-C. As a reliable study tool and a possible API candidate, it's ideal for pharmaceutical businesses, CRO/CDMOs, and research schools. Its targeted mechanism, good tolerability data, and structural similarity to endogenous uroguanylin give it a strong position compared to other secretagogues. You can protect your program at every stage, from the first bench work to the regulatory filing, by buying from a manufacturer that gives you verified purity data, full batch paperwork, and a choice of flexible packing options.

FAQ

Q1: What is the difference between plecanatide powder and tablets?

A: Plecanatide powder is the bulk API form that is used in research and to make medicines. Tablets are the end dosage form that is sold under the Trulance brand name. Most of the time, B2B buyers get the powder to help with research, formulation development, or bioequivalence studies.

Q2: Is plecanatide soluble in aqueous buffers?

A: Yes, plecanatide can be dissolved in neutral aqueous buffers. This means that it can be used for in vitro assay preparation and formulation studies in the lab.

Q3: How does plecanatide compare to linaclotide for research use?

A: Both are GC-C agonists that are used in similar ways in gut studies. Plecanatide can be used as an extra or alternative reference molecule for studies of gut movement and secretion because it reacts to changes in pH and has a structure that is similar to uroguanylin.

Q4: How can I verify supplier quality before placing a bulk order?

A: Ask for a COA, an HPLC purity report, and paperwork that is special to the batch. Make sure the provider is ISO certified and ask if they can help with MSDS and DMF. Each package from Xi'an Yihui comes with all the usual paperwork.

Q5: Is this product available for individual purchase?

A: Not at all. Plecanatide powder from Xi'an Yihui is only sold to scientists for study purposes and not to regular people. Only orders from registered businesses and institutions will be filled.

Partner With Xi'an Yihui — Your Trusted Plecanatide Powder Supplier

Since 2010, Xi'an Yihui Bio-technology Co., Ltd. has sold drugs and fine chemicals of the highest quality to customers in over 100 countries. Our plecanatide powder is ≥98.0% pure according to HPLC, comes with full batch documentation, ISO certification, and can be shipped right away because we have it in stock. Whether you need small amounts for research or a lot of them, we can help you 24/7 and offer flexible packaging at competitive prices. Send us an email at sales@yihuipharm.com to get a quote right away.

References

1. Miner, P. B., et al. "Plecanatide in Patients with Chronic Idiopathic Constipation." American Journal of Gastroenterology, 2017.

2. Brenner, D. M., et al. "Efficacy and Safety of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation." American Journal of Gastroenterology, 2018.

3. Shailubhai, K., et al. "Plecanatide and Dolcanatide, Novel Guanylate Cyclase-C Agonists, Ameliorate Gastrointestinal Inflammation." World Journal of Gastrointestinal Pharmacology and Therapeutics, 2015.

4. U.S. Food and Drug Administration. "Trulance (Plecanatide) Prescribing Information." FDA Drug Label, 2017.

5. Castro, J., et al. "Linaclotide Inhibits Colonic Nociceptors and Relieves Abdominal Pain via Guanylate Cyclase-C and Extracellular Cyclic Guanosine 3′,5′-Monophosphate." Gastroenterology, 2013.

6. Bharucha, A. E., and Lacy, B. E. "Mechanisms, Evaluation, and Management of Chronic Constipation." Gastroenterology, 2020.