guanylate cyclase-C agonist
Linaclotide companies
Answer
Public registers name 3 licence holders, 16 ingredient makers with a drug master file, 8 bulk ingredient labelers, 1 US labeler, 26 trial sponsors and 1 recalling firm for Linaclotide.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
3 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| ABBVIE CORPORATION | CONSTELLA (DIN 02417162), Marketed Regulator Health Canada CONSTELLA (DIN 02417170), Marketed Regulator Health Canada CONSTELLA (DIN 02469510), Marketed Regulator Health Canada |
|---|---|
| AbbVie Deutschland GmbH & Co. KG | Constella (EMEA/H/C/002490), Authorised Regulator EMA |
| ABBVIE LTD | CONSTELLA 290 MICROGRAMS HARD CAPSULES, PLGB 41042/0079, Authorised Regulator MHRA |
API MANUFACTURER
16 companies
Filed a drug master file with FDA for the active ingredient.
| AURO PEPTIDES LTD | DMF 29708, type II, active, submitted 2015-09-22 Regulator FDA drug master file list |
|---|---|
| BACHEM AMERICAS INC | DMF 28273, type II, inactive, submitted 2014-05-05 Regulator FDA drug master file list |
| CHENGDU SHENGNUO BIOPHARM CO LTD | DMF 35812, type II, active, submitted 2021-04-06 Regulator FDA drug master file list |
| CORDEN PHARMA COLORADO INC | DMF 24992, type II, active, submitted 2011-05-27 Regulator FDA drug master file list |
| HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD | DMF 42040, type II, active, submitted 2025-06-12 Regulator FDA drug master file list |
| HANGZHOU THINHEAL PHARMA-TECH CO LTD | DMF 39901, type II, active, submitted 2024-06-28 Regulator FDA drug master file list |
| HYBIO PHARMACEUTICAL CO LTD | DMF 32314, type II, active, submitted 2017-12-28 Regulator FDA drug master file list DMF 37370, type II, active, submitted 2022-08-17 Regulator FDA drug master file list |
| MSN LIFE SCIENCES PRIVATE LTD | DMF 30421, type II, inactive, submitted 2016-03-29 Regulator FDA drug master file list DMF 31351, type II, active, submitted 2017-02-01 Regulator FDA drug master file list |
| POLYPEPTIDE LABORATORIES INC | DMF 25025, type II, active, submitted 2011-06-07 Regulator FDA drug master file list |
| POLYPEPTIDE LABORATORIES SWEDEN AB | DMF 25021, type II, active, submitted 2011-06-01 Regulator FDA drug master file list |
| Sun Pharmaceutical Industries Ltd. | DMF 30266, type II, active, submitted 2016-11-16 Regulator FDA drug master file list |
| SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTD | DMF 42635, type II, active, submitted 2025-09-23 Regulator FDA drug master file list |
| TAPI NL BV | DMF 30274, type II, active, submitted 2016-03-10 Regulator FDA drug master file list |
| WISDOM PHARMACEUTICAL CO LTD | DMF 44235, type II, active, submitted 2026-05-29 Regulator FDA drug master file list |
| ZHEJIANG PEPTITES BIOTECH CO LTD | DMF 42049, type II, active, submitted 2025-06-08 Regulator FDA drug master file list |
| ZHEJIANG SUPOR PHARMACEUTICALS CO LTD | DMF 43837, type II, active, submitted 2026-03-16 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
8 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Aurobindo Pharma Limited | Linaclotide, BULK INGREDIENT Regulator openFDA |
|---|---|
| CHENGDU SHENGNUO BIOPHARM CO LTD | Linaclotide, BULK INGREDIENT Regulator openFDA |
| CORDEN PHARMA COLORADO INC | linaclotide, BULK INGREDIENT Regulator openFDA |
| HYBIO PHARMACEUTICAL CO LTD | Linaclotide, BULK INGREDIENT Regulator openFDA |
| MSN Life Sciences Private Limited | Linaclotide, BULK INGREDIENT Regulator openFDA |
| POLYPEPTIDE LABORATORIES INC | linaclotide, BULK INGREDIENT Regulator openFDA |
| SUN PHARMACEUTICAL INDUSTRIES INC | Linaclotide, BULK INGREDIENT Regulator openFDA |
| Zhejiang SyncoTide Bio-pharmaceutical Co., Ltd | Linaclotide, BULK INGREDIENT Regulator openFDA |
US LABELER
1 company
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Allergan, Inc. | linaclotide, DRUG FOR FURTHER PROCESSING Regulator openFDA Linzess, NDA Regulator openFDA |
|---|
TRIAL SPONSOR
26 companies
Sponsors registered clinical trials of the peptide.
| Forest Laboratories | 9 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Ironwood Pharmaceuticals, Inc. | 9 registered trials Trial register ClinicalTrials.gov |
| AbbVie | 4 registered trials Trial register ClinicalTrials.gov |
| Astellas Pharma Inc | 4 registered trials Trial register ClinicalTrials.gov |
| AbbVie Deutschland GmbH & Co. KG | 2 registered trials Trial register EU CTIS |
| AstraZeneca | 2 registered trials Trial register ClinicalTrials.gov |
| Mayo Clinic | 2 registered trials Trial register ClinicalTrials.gov |
| University of Nottingham | 2 registered trials Trial register ClinicalTrials.gov |
| Allergan | 1 registered trial Trial register ClinicalTrials.gov |
| Augusta University | 1 registered trial Trial register ClinicalTrials.gov |
| Changhai Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Haifeng Lan | 1 registered trial Trial register ClinicalTrials.gov |
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| McMaster University | 1 registered trial Trial register ClinicalTrials.gov |
| Md Mehedi Shahriar | 1 registered trial Trial register ClinicalTrials.gov |
| RenJi Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Second Affiliated Hospital of Xi'an Jiaotong University | 1 registered trial Trial register ClinicalTrials.gov |
| Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 1 registered trial Trial register ClinicalTrials.gov |
| Texas Tech University Health Sciences Center, El Paso | 1 registered trial Trial register ClinicalTrials.gov |
| TriHealth Inc. | 1 registered trial Trial register ClinicalTrials.gov |
| Universitaire Ziekenhuizen KU Leuven | 1 registered trial Trial register ClinicalTrials.gov |
| University of Florida | 1 registered trial Trial register ClinicalTrials.gov |
| University of Virginia | 1 registered trial Trial register ClinicalTrials.gov |
| University of Wisconsin, Madison | 1 registered trial Trial register ClinicalTrials.gov |
| Wingate Institute of Neurogastroenterology | 1 registered trial Trial register ClinicalTrials.gov |
| Zhiguo Liu | 1 registered trial Trial register ClinicalTrials.gov |
RECALLING FIRM
1 company
Recalled a product naming the peptide (FDA enforcement report).
| Cardinal Health Inc. | Class II recall, Terminated, 2021-06-02 Regulator openFDA |
|---|
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.