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 $1.4bn 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).

Astellas Pharma Overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,296,163 million for the fiscal year ended March 2022 (FY2022), an increase of 3.7% over FY2021. In FY2022, the company’s operating margin was 12.4%, compared to an operating margin of 11.7% in FY2021. In FY2022, the company recorded a net margin of 9.6%, compared to a net margin of 9.7% in FY2021. The company reported revenues of JPY380,394 million for the second quarter ended September 2022, a decrease of 0.4% 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.