Track linaclotide in Peptimes™
Linaclotide is a guanylate cyclase-C agonist, a peptide of 14 amino acids. It is the active ingredient in Linzess and generic linaclotide capsules, FDA-approved prescription medicines taken by mouth. (Source: DailyMed label.)
Is linaclotide FDA-approved?
Yes, as specific products: Linzess capsules and a generic linaclotide capsule are FDA-approved, by prescription, for the uses in their labels.
Linaclotide
Also: Linzess, Constella, MD-1100, ASP0456
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- Oral
- Updated
- 1 Nov 2026
US regulatory status
FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Linzess (linaclotide) capsules
Oral
Irritable bowel syndrome with constipation (IBS-C) in adults and children aged 7 and older; chronic idiopathic constipation in adults; and functional constipation in children aged 2 and older.
Source: DailyMed label, checked 1 Nov 2026
Generic linaclotide capsules (Actavis), with Linzess as the reference product
Oral
As stated on its label, which may not list every use on Linzess's (approved through an abbreviated new drug application, ANDA).
Source: Drugs@FDA, checked 1 Nov 2026
Investigational
No, for the products and uses above.
Source: Drugs@FDA, checked 1 Nov 2026
How to track it in Peptimes
Add linaclotide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.
- Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell linaclotide or any other compound.
More sources
- FDA, Drugs@FDA, NDA 202811 (Linzess) and ANDA 211255 (generic linaclotide), checked 1 Nov 2026: product, route and marketing status.
- FDA, Global Substance Registration System, Linaclotide, checked 1 Nov 2026: the code names MD-1100 and ASP0456.
Related pages
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