Linaclotide is a Synthetic Peptide owned by Ironwood Pharmaceuticals, and is involved in 42 clinical trials, of which 37 were completed, and 5 are ongoing.

Linaclotide is an agonist of guanylate cyclase type-C (GC-C), a receptor found on epithelial cells lining the intestine. Linaclotide promotes activation of the CFTR chloride channel. Activation of intestinal GC-C induces secretion of fluid, sodium and bicarbonate in the intestinal lumen. The activation of GC-C leads to increases in cyclic guanosine monophosphate (cGMP), anion secretion, fluid secretion, and intestinal transit. In addition, both linaclotide and cGMP demonstrated anti-nociceptive effects in several preclinical models of visceral pain.

The revenue for Linaclotide is expected to reach a total of $17.6bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Linaclotide NPV Report.

Linaclotide is originated and owned by Ironwood Pharmaceuticals. Astellas Pharma and AbbVie are the other companies associated in development or marketing of Linaclotide.

Linaclotide Overview

Linaclotide (Linzess, Constella, Axulta) is an anti-constipation agent. It is formulated as  hard gelatin capsules and tablets for oral route of administration. Linaclotide is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) when dietary fibre, laxatives and stool softeners have not been sufficient and with adequate constipation minimisation dietary support.

Linaclotide is under development for the chronic idiopathic constipation, functional constipation (age 6 to 17 years), IBS-C in pediatrics (age 6 to 17 years), viseral pain and hypersensitivity. It was also under development for colon cancer and opioid-induced constipation (OIC) and CIC in pediatrics (age 7 to 17 years).

AbbVie Overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic diseases, rheumatological diseases, neurological disorders, viral diseases, skin diseases, complications associated with cystic fibrosis, pain related to endometriosis, diseases of the gastrointestinal tract, various types of cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of cystic fibrosis, women’s health, various cancers, neurological disorders and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

The company reported revenues of (US Dollars) US$56,197 million for the fiscal year ended December 2021 (FY2021), an increase of 22.7% over FY2020. In FY2021, the company’s operating margin was 31.9%, compared to an operating margin of 24.8% in FY2020. In FY2021, the company recorded a net margin of 20.5%, compared to a net margin of 10.1% in FY2020. The company reported revenues of US$14,812 million for the third quarter ended September 2022, an increase of 1.6% over the previous quarter.

Quick View – Linaclotide

Report Segments
  • Innovator (NME)
Drug Name
  • Linaclotide
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Immunology
  • Oncology
  • Toxicology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.