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Fresenius Kabi

🇧🇪Belgium
Ownership
Subsidiary
Established
1999-01-01
Employees
-
Market Cap
-
Website
http://www.fresenius-kabi.com

Clinical Trials

51

Active:1
Completed:36

Trial Phases

4 Phases

Phase 1:3
Phase 3:7
Phase 4:17
+1 more phases

Drug Approvals

18

SFDA:18

Drug Approvals

AMINOVEN

Approval Date
Jul 18, 2025
SFDA

DIPEPTIVEN 20GM/100ML CONC

Approval Date
Jul 18, 2025
SFDA

ZYVOX 2 MG/ML SOLUTION FOR INFUSION

Approval Date
Jul 18, 2025
SFDA

Foscavir

Approval Date
Jul 18, 2025
SFDA

SmofKabiven extra Nitrogen

Approval Date
Jul 18, 2025
SFDA

SmofKabiven extra Nitrogen

Approval Date
Jul 18, 2025
SFDA

Oleovit D3 Oral drops

Approval Date
Jul 18, 2025
Company
Fresenius Kabi Austria Gmbh
SFDA

SMOFLIPID

Approval Date
Jul 18, 2025
SFDA

SMOFLIPID

Approval Date
Jul 18, 2025
SFDA

Paracetamol Kabi

Approval Date
Jul 18, 2025
SFDA
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Clinical Trials

Distribution across different clinical trial phases (39 trials with phase data)• Click on a phase to view related trials

Phase 4
17 (43.6%)
Not Applicable
12 (30.8%)
Phase 3
7 (17.9%)
Phase 1
3 (7.7%)

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients with PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Phase 4
Recruiting
Conditions
Parenteral Nutrition Associated Liver Disease (PNALD)
Essential Fatty Acid Deficiency
Malnutrition
Pediatric ALL
Interventions
First Posted Date
2024-02-23
Last Posted Date
2025-02-28
Lead Sponsor
Fresenius Kabi
Target Recruit Count
40
Registration Number
NCT06274788
Locations
🇺🇸

University of California Los Angeles, Los Angeles, California, United States

🇺🇸

Memorial Health Service, Fountain Valley, California, United States

🇺🇸

Board of Regents of the University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

and more 2 locations

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Phase 4
Recruiting
Conditions
Malnutrition, Child
Malnutrition
Essential Fatty Acid Deficiency (EFAD)
Parenteral Nutrition Associated Cholestasis
Interventions
Drug: SMOFlipid® (lipid injectable emulsion)
First Posted Date
2023-09-22
Last Posted Date
2025-08-20
Lead Sponsor
Fresenius Kabi
Target Recruit Count
100
Registration Number
NCT06049680
Locations
🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

🇺🇸

The University of Chicago, Chicago, Illinois, United States

🇺🇸

Riley Hospital for Children, Indianapolis, Indiana, United States

and more 5 locations

Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care

Phase 3
Completed
Conditions
Nutrition Therapy
Critical Illness
Interventions
First Posted Date
2022-02-25
Last Posted Date
2024-02-21
Lead Sponsor
Fresenius Kabi
Target Recruit Count
56
Registration Number
NCT05257031
Locations
🇷🇺

Municipal Clinical Hospital No. 40 of Moscow Healthcare Department, Moscow, Russian Federation

bIosimilar of aDalimumab, an European evAluation

Conditions
Ulcerative Colitis
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Crohn Disease
First Posted Date
2022-01-13
Last Posted Date
2022-01-13
Lead Sponsor
Fresenius Kabi
Target Recruit Count
1050
Registration Number
NCT05190484

A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

Completed
Conditions
Ankylosing Spondylitis
Ulcerative Colitis
Psoriatic Arthritis
Crohn Disease
Rheumatoid Arthritis
Psoriasis
First Posted Date
2021-09-21
Last Posted Date
2023-07-19
Lead Sponsor
Fresenius Kabi
Target Recruit Count
754
Registration Number
NCT05051943
Locations
🇫🇷

CHRU de Nancy - Hôpitaux de Brabois, Vandœuvre-lès-Nancy, France

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News

CivicaScript Announces Low-Cost Ustekinumab Biosimilar Distribution to Expand Access to Inflammatory Disease Treatment

CivicaScript will distribute ustekinumab-aauz biosimilar starting January 1, 2026, targeting chronic inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Polpharma Biologics and Fresenius Kabi Partner on Vedolizumab Biosimilar for Inflammatory Bowel Disease

Polpharma Biologics has signed a global licensing agreement with Fresenius Kabi for PB016, a proposed biosimilar to Entyvio (vedolizumab) targeting moderate-to-severe ulcerative colitis and Crohn's disease.

Teva Partners with Formycon to Commercialize Stelara Biosimilar Fymskina in Germany

Formycon AG has entered into a distribution agreement with Teva's subsidiary Ratiopharm for the semi-exclusive commercialization of its Stelara biosimilar FYB202, branded as Fymskina, in Germany.

Tocilizumab Biosimilar CT-P47 Demonstrates Long-Term Efficacy and Safety in Rheumatoid Arthritis Treatment

CT-P47, a tocilizumab biosimilar, showed comparable efficacy and safety to reference Actemra over 52 weeks in a phase 3 trial involving 444 rheumatoid arthritis patients.

Fresenius Kabi Launches First Generic Iodixanol Contrast Agent in Canada, Addressing Critical Supply Shortages

Fresenius Kabi Canada launched Iodixanol Injection 270 and 320, marking the first generic injectable iodinated contrast media available in the Canadian market.

mAbxience Expands European Biosimilar Access Through Strategic Partnerships with Abiogen Pharma and Corapharm

mAbxience has signed two strategic licensing agreements to commercialize biosimilar candidates across Italy and Southeast Europe, partnering with Abiogen Pharma and Corapharm respectively.

Fresenius Kabi Launches Tyenne®, Canada's First Tocilizumab Biosimilar for Autoimmune Conditions

Fresenius Kabi has commercially launched Tyenne®, the first and only tocilizumab biosimilar available in Canada, offered in both subcutaneous and intravenous formulations.

Fresenius Kabi Launches 30 mg/30 mL Epinephrine Injection for Emergency Care and Septic Shock

Fresenius Kabi has introduced Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States, expanding its emergency medicine portfolio.

Smart Drug Delivery Systems Market Poised for 17% Growth as Chronic Disease Management Evolves

The global smart drug delivery systems market reached $12 billion in 2024 and is projected to grow at a CAGR of 17% through 2034, driven by rising chronic disease prevalence and technological advancements.

Pacira BioSciences Settles EXPAREL Patent Litigation with Fresenius Kabi, Securing Market Exclusivity Until 2030

Pacira BioSciences has reached a settlement with Fresenius Kabi and other companies regarding patent litigation for its non-opioid pain therapy EXPAREL, allowing limited generic entry beginning in early 2030.

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