Calliditas Therapeutics
- 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
28
Trial Phases
5 Phases
Drug Approvals
1
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (28 trials with phase data)• Click on a phase to view related trials
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
- First Posted Date
- 2024-12-02
- Last Posted Date
- 2025-08-27
- Lead Sponsor
- Calliditas Therapeutics AB
- Target Recruit Count
- 60
- Registration Number
- NCT06712407
- Locations
- 🇺🇸
UCI Health-UCI Medical Center, Orange, California, United States
🇺🇸UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice, San Francisco, California, United States
🇺🇸Stanford University, Stanford, California, United States
A Study to Evaluate Setanaxib in Patients With Alport Syndrome
- First Posted Date
- 2024-02-23
- Last Posted Date
- 2025-08-12
- Lead Sponsor
- Calliditas Therapeutics AB
- Target Recruit Count
- 19
- Registration Number
- NCT06274489
- Locations
- 🇦🇹
Medizinische Universitaet Wien, Vienna, Wien, Austria
🇨🇿Fakultni Nemocnice Hradec Kralove, Hradec Králové, Czechia
🇨🇿Fakultni Nemocnice Olomouc, Olomouc, Czechia
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)
- Conditions
- Primary IgA Nephropathy
- Interventions
- Drug: Nefecon 16mg daily
- First Posted Date
- 2020-09-09
- Last Posted Date
- 2025-02-10
- 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
Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects
- 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
- 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
- Prev
- 1
- 2
- 3
- Next
News
Seven Real-World Studies Demonstrate NEFECON's Efficacy in IgA Nephropathy Treatment Across Diverse Patient Populations
Seven new real-world evidence studies from leading Chinese hospitals will be presented at the 18th International IgA Nephropathy Symposium, demonstrating NEFECON's efficacy and safety across diverse patient populations including pediatric cases and those with renal insufficiency.
Hansa Biopharma Appoints Dr. Richard Philipson as Chief Medical Officer to Lead Next Development Phase
Hansa Biopharma has appointed Dr. Richard Philipson as Chief Medical Officer effective July 14, bringing over 25 years of industry experience to the commercial-stage biopharmaceutical company.
Liver Cirrhosis Pipeline Shows Strong Growth with 30+ Therapies in Development Across Multiple Clinical Phases
DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ liver cirrhosis therapies, with promising candidates like Rezdiffra, efruxifermin, and belapectin showing significant clinical progress.
Hansa Biopharma Appoints Renée Aguiar-Lucander as New CEO, Marking New Growth Phase
• Renée Aguiar-Lucander has been appointed as the new CEO of Hansa Biopharma AB, effective immediately, replacing Søren Tulstrup who steps down after seven years with the company. • Aguiar-Lucander brings significant experience from her seven-year tenure as CEO of Calliditas Therapeutics, where she led a successful dual NASDAQ listing and launched the first approved drug for IgA nephropathy in the U.S. • The leadership change signals Hansa Biopharma's transition into a new growth phase, with the Board expressing confidence in Aguiar-Lucander's ability to advance the company's strategic positioning.
Phase 3 Success: Nefecon Shows Promise in Treating IgA Nephropathy, Filing Planned for Early 2021
• Calliditas Therapeutics' Nefecon demonstrated significant efficacy in Phase 3 trial, showing 31% reduction in proteinuria compared to 5% in placebo for IgA nephropathy treatment. • The drug showed favorable safety profile consistent with budesonide, with key secondary endpoint demonstrating 7% treatment benefit in estimated glomerular filtration rate versus placebo. • Company plans FDA filing for accelerated approval in Q1 2021, followed by EMA submission in H2, targeting 130,000-150,000 potential patients in US market.
Taiwan TFDA Approves Nefecon for Primary IgA Nephropathy Treatment
The Taiwan Food and Drug Administration (TFDA) has approved NEFECON® for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
Calliditas Therapeutics Pioneered Novel Endpoint for IgAN Drug Approval
Calliditas Therapeutics utilized a novel renal primary surrogate endpoint, proteinuria reduction, in a Phase III trial for IgA nephropathy (IgAN).
NOX Inhibitors Show Promise in Fibrotic Diseases and Cancer Treatment
NADPH oxidase (NOX) inhibitors are emerging as potential treatments for fibrotic diseases and cancers by reducing reactive oxygen species (ROS) production.
FDA Grants Full Approval to Travere's Filspari for IgA Nephropathy
The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for IgA nephropathy, allowing broader use for patients at risk of disease progression.