Organization (Industry)
BIOTEST ApS
ClinicalTrials.gov lists BIOTEST ApS as lead sponsor of 20 trials. It has 9 active development programs and 1 approved asset.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers BIOTEST ApS: 20 lead-sponsored trials and 4 legal-entity registrations.
Disease areas (32)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Community-Acquired Pneumonia | 4 |
| Hepatitis B | 4 |
| Cytomegalovirus Infections | 3 |
| Multiple Myeloma | 3 |
| Afibrinogenemia | 2 |
Showing 5 of 32 disease areas.
Trials by start year as sponsor or collaborator (17)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2023 | 1 |
| 2022 | 3 |
| 2021 | 2 |
| 2020 | 1 |
| 2018 | 1 |
| 2017 | 1 |
| 2016 | 2 |
| 2015 | 1 |
| 2013 | 3 |
| 2012 | 2 |
Showing 10 of 17 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (9)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Trimodulin | Community-Acquired Pneumonia | Phase 3 | 3 |
| Trimodulin | Respiratory Distress Syndrome | Phase 3 | 2 |
| Trimodulin | COVID-19 | Phase 3 | 2 |
| BT524 | Afibrinogenemia | Phase 3 | 2 |
| BT097 | Cytomegalovirus Infections | Phase 3 | 1 |
Showing 5 of 9 active programs.
Approved assets (1)
| Drug | Trials |
|---|---|
| Hepatitis B Immune Globulin (Boca HBVIg) | 3 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 63% hit target (n=8) | 22% on time (n=9) |
Journals published in (41)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| American journal of respiratory and critical care medicine | 4 |
| Critical care (London, England) | 4 |
| Critical care medicine | 4 |
| The Cochrane database of systematic reviews | 3 |
| Transplant international : official journal of the European Society for Organ Transplantation | 3 |
Showing 5 of 41 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 68 | 6 | 2025-12-02 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 2 | 2012-03-30 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Biotest AG | Dreieich, DE | EMA, FDA |
Organization relationships (13)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Grifols Therapeutics LLC | Co sponsors trial with | 2 |
| Syneos Health (United States) | Uses vendor | 2 |
| Syneos Health (United States) | Co sponsors trial with | 2 |
| Icon Plc | Uses vendor | 2 |
| Charta Foundation | Co sponsors trial with | 2 |
Showing 5 of 13 relationships.
Latest dated events (124)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-12-02 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-04-01 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-01-07 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2024-11-21 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2023-10-10 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 124 events.
Biomarker capability evidence (48)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CD4 | Trial collaborator | Named in trial inclusion criteria |
| CD4 | Trial sponsor | Named in trial inclusion criteria |
| CIRSR | Trial sponsor | Primary endpoint in a Phase 3 trial |
| CRP | Trial sponsor | Named in trial inclusion criteria |
| CRP | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 48 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda inspection record, fda recalls, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.