Calliditas Therapeutics

🇸🇪Sweden

Country: 🇸🇪Sweden

Ownership: Public

Established: 1991-01-01

Employees: 195

Market Cap: -

Website: http://www.pharmalink.se

Introduction: Calliditas Therapeutics AB is a commercial-stage biopharma company focused on identifying, developing, and commercializing novel treatments in orphan indications, initially focusing on renal and hepatic diseases with unmet medical needs. The company's pipeline candidate is TARPEYO medication to reduce proteinuria in IgA nephropathy.

Clinical Trials

Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients with Primary IgA Nephropathy

Phase 4

Not yet recruiting

Conditions: IgA Nephropathy

Interventions: Drug: TARPEYO®

First Posted Date: 2024-12-02

Last Posted Date: 2024-12-02

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 60

Registration Number: NCT06712407

A Study to Evaluate Setanaxib in Patients With Alport Syndrome

Phase 1

Recruiting

Conditions: Alport Syndrome

Interventions: Drug: Setanaxib
Drug: Placebo

First Posted Date: 2024-02-23

Last Posted Date: 2024-11-01

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 18

Registration Number: NCT06274489

Locations: 🇬🇧
Nottingham City Hospital, Nottingham, United Kingdom
🇦🇹
Medizinische Universitaet Wien, Vienna, Wien, Austria
🇫🇷
HCL Hopital Edouard Herriot, Lyon, France

and more 17 locations

Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)

Phase 3

Completed

Conditions: Primary IgA Nephropathy

Interventions: Drug: Nefecon 16mg daily

First Posted Date: 2020-09-09

Last Posted Date: 2024-10-26

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 119

Registration Number: NCT04541043

Locations: 🇺🇸
13 Investigator sites, Palo Alto, California, United States
🇪🇸
4 Investigator sites, Barcelona, Spain
🇬🇧
6 Investigator sites, Leicester, United Kingdom

and more 4 locations

Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects

Phase 1

Completed

Conditions: Phase 1

Interventions: Drug: Setanaxib

First Posted Date: 2020-03-30

Last Posted Date: 2022-06-30

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 64

Registration Number: NCT04327089

Locations: 🇫🇷
Eurofins Optimed, Gières, France

Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

Phase 1

Completed

Conditions: Phase 1

Interventions: Drug: GKT137831

First Posted Date: 2018-11-14

Last Posted Date: 2022-06-30

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 15

Registration Number: NCT03740217

Locations: 🇫🇷
Eurofins Optimed, Gières, France

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Phase 3

Completed

Conditions: Primary IgA Nephropathy

Interventions: Drug: Nefecon
Drug: Placebo oral capsule

First Posted Date: 2018-08-23

Last Posted Date: 2024-12-03

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 365

Registration Number: NCT03643965

Locations: 🇺🇸
Stanford University Medical Center, 777 Welch Rd, Palo Alto, California, United States
🇺🇸
University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor, Lexington, Kentucky, United States
🇺🇸
University of Florida-Gainesville, Gainesville, Florida, United States

and more 139 locations

Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.

Phase 2

Completed

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: GKT137831
Drug: Placebo oral capsule

First Posted Date: 2017-07-21

Last Posted Date: 2022-06-29

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 111

Registration Number: NCT03226067

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
UPMC Center for Liver Diseases, Pittsburgh, Pennsylvania, United States
🇺🇸
Ventura Clinical Trials, Ventura, California, United States

and more 58 locations

Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy

Interventions: Drug: GKT137831
Drug: Placebo

First Posted Date: 2013-12-12

Last Posted Date: 2015-03-30

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 200

Registration Number: NCT02010242

Locations: 🇺🇸
Advanced Arizona Clinical Research, Tucson, Arizona, United States
🇺🇸
The Endocrine Medical Group, Inc, Orange, California, United States
🇺🇸
Clinical Research of South Florida, Coral Gables, Florida, United States

and more 45 locations

The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

Phase 2

Completed

Conditions: Primary IgA Nephropathy

Interventions: Drug: NEFECON
Other: Placebo

First Posted Date: 2012-11-30

Last Posted Date: 2015-09-24

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 150

Registration Number: NCT01738035

Locations: 🇧🇪
University Hospital of Antwerp, Antwerp, Belgium
🇨🇿
Charles University & General University Hospital, Prague, Czech Republic
🇨🇿
Institut klinické a experimentální medicíny, Prague, Czech Republic

and more 53 locations

Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

Phase 2

Completed

Conditions: IGA Nephropathy

Interventions: Drug: Budesonide

First Posted Date: 2008-10-07

Last Posted Date: 2009-04-21

Lead Sponsor: Calliditas Therapeutics AB

Target Recruit Count: 20

Registration Number: NCT00767221

Locations: 🇸🇪
Linköping University Hospital, Linköping, Sweden
🇸🇪
Uppsala University Hospital, Uppsala, Sweden
🇸🇪
Huddinge University Hospital, Stockholm, Sweden

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