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Biotest

🇩🇪Germany
Ownership
-
Established
1946-01-01
Employees
-
Market Cap
$1.4B
Website
http://www.biotest.de

Clinical Trials

14

Active:0
Completed:10

Trial Phases

2 Phases

Phase 2:6
Phase 3:8

Drug Approvals

14

SFDA:14

Drug Approvals

HEPATECT CP

Approval Date
Jul 18, 2025
SFDA

INTRATECT 50MG-ML SOLUTION FOR INFUSION

Approval Date
Jul 18, 2025
SFDA

INTRATECT 50MG-ML SOLUTION FOR INFUSION

Approval Date
Jul 18, 2025
SFDA

PENTAGLOBIN AMP I.V

Approval Date
Jul 18, 2025
SFDA

PENTAGLOBIN

Approval Date
Jul 18, 2025
SFDA

FOVEPTA

Approval Date
Jul 18, 2025
SFDA

PENTAGLOBIN

Approval Date
Jul 18, 2025
SFDA

HEPATECT CP

Approval Date
Jul 18, 2025
SFDA

INTRATECT 50MG-ML SOLUTION FOR INFUSION

Approval Date
Jul 18, 2025
SFDA

HUMAN ALBUMIN 20% +INFUSION SET

Approval Date
Jul 18, 2025
SFDA
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Clinical Trials

Distribution across different clinical trial phases (14 trials with phase data)• Click on a phase to view related trials

Phase 3
8 (57.1%)
Phase 2
6 (42.9%)

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

Phase 3
Recruiting
Conditions
Community-acquired Pneumonia
Interventions
Drug: Placebo (human albumin 1%)
First Posted Date
2023-02-10
Last Posted Date
2025-07-23
Lead Sponsor
Biotest
Target Recruit Count
590
Registration Number
NCT05722938
Locations
🇺🇸

Pulmonary Associates of Mobile, P.C., Mobile, Alabama, United States

🇺🇸

University of California San Francisco-Fresno, Fresno, California, United States

🇺🇸

UC Davis Health, Sacramento, California, United States

and more 131 locations

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

Phase 3
Terminated
Conditions
COVID-19
Pneumonia
Community-acquired Pneumonia
Bacterial Pneumonia
Respiratory Infection
Viral Pneumonia
Fungal Pneumonia
Acute Respiratory Distress Syndrome
Interventions
Drug: Placebo (human albumin 1%)
First Posted Date
2022-09-07
Last Posted Date
2025-06-08
Lead Sponsor
Biotest
Target Recruit Count
107
Registration Number
NCT05531149
Locations
🇦🇷

Investigational Site #5401, Buenos Aires, Argentina

🇦🇷

Investigational Site #5403, Cordoba, Argentina

🇦🇷

Investigational Site #5402, Córdoba, Argentina

and more 61 locations

Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

Phase 3
Terminated
Conditions
Congenital Cytomegalovirus Infection
Interventions
First Posted Date
2021-12-27
Last Posted Date
2025-03-10
Lead Sponsor
Biotest
Target Recruit Count
48
Registration Number
NCT05170269
Locations
🇩🇪

4906, Berlin, Germany

🇩🇪

4903, Bonn, Germany

🇩🇪

4902, Erlangen, Germany

and more 2 locations

Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19

Phase 2
Completed
Conditions
Covid19
Interventions
Other: Placebo (human albumin 1%)
First Posted Date
2020-10-06
Last Posted Date
2023-01-10
Lead Sponsor
Biotest
Target Recruit Count
166
Registration Number
NCT04576728
Locations
🇧🇷

Investigational site # 5503, Porto Alegre, Brazil

🇧🇷

Investigational site # 5502, Santo André, Brazil

🇧🇷

Investigational site # 5505, Santo André, Brazil

and more 14 locations

Adjusted Fibrinogen Replacement Strategy

Phase 3
Completed
Conditions
Bleeding Disorder
Hypofibrinogenemia; Acquired
Interventions
Biological: FFP/Cryo
First Posted Date
2018-02-23
Last Posted Date
2025-06-13
Lead Sponsor
Biotest
Target Recruit Count
222
Registration Number
NCT03444324
Locations
🇧🇪

Site 02, Jette, Belgium

🇧🇪

Site 01, Leuven, Belgium

🇨🇿

Site 54, Brno, Czechia

and more 16 locations
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News

Grifols' Fibrinogen Concentrate BT524 Demonstrates Non-Inferiority in Phase III Trial for Surgical Bleeding

Grifols' fibrinogen concentrate BT524 met its primary endpoint in the Phase III AdFIrst trial, demonstrating non-inferiority to standard of care for treating bleeding in acquired fibrinogen deficiency during major surgery.

Biotest Reports 6% Sales Growth in 2024, FDA Approves Yimmugo for US Market

Biotest AG achieved €726.2 million in sales for 2024, a 6.1% increase driven primarily by strong performance of Intratect and Yimmugo, with EBIT reaching €94.5 million at the upper end of forecast range.

Biotest Submits Fibrinogen Biologics License Application to FDA

Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency.

Grifols' Biotest Achieves Phase 3 Success for Fibrinogen Concentrate in Acquired Deficiency Treatment

Biotest's fibrinogen concentrate BT524 met its primary endpoint in the AdFIrst phase 3 trial, demonstrating non-inferiority to standard care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency.

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