Organization (Industry)
KEDRION S.P.A.
ClinicalTrials.gov lists KEDRION S.P.A. as lead sponsor of 10 trials. It has 12 active development programs and 3 approved assets.
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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: 3 registered with a 2026 start date. The dashed outline is the pace from the 2 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.
Logo Kedrion Biopharma, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers KEDRION S.P.A.: 10 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (13)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Agammaglobulinemia | 3 |
| Primary Immunodeficiency Diseases | 3 |
| Amyloidosis | 1 |
| Factor X Deficiency | 1 |
| Hemorrhage | 1 |
Showing 5 of 13 disease areas.
Trials by start year as sponsor or collaborator (8)
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 |
|---|---|
| 2026 (partial year) | 3 |
| 2025 | 1 |
| 2021 | 1 |
| 2019 | 1 |
| 2016 | 1 |
| 2015 | 1 |
| 2013 | 1 |
| 2012 | 1 |
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 (12)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Kedrion IVIG 10% | Agammaglobulinemia | Phase 3 | 3 |
| Kedrion IVIG 10% | Primary Immunodeficiency Diseases | Phase 3 | 3 |
| Kedrion IVIG 10% | Thrombocytopenia | Phase 3 | 1 |
| Kedrion IVIG 10% | Purpura, Thrombocytopenic, Idiopathic | Phase 3 | 1 |
| Kedrion IVIG 10% | Hemorrhage | Phase 3 | 1 |
Showing 5 of 12 active programs.
Approved assets (3)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Kedbumin 25% | 1 |
| Coagadex | 1 |
| Human Albumin | 1 |
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 |
|---|---|
| 1 of 4 hit target (n=4) | 3 of 3 on time (n=3) |
Journals published in (2)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Ophthalmology | 1 |
| The Lancet. Neurology | 1 |
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 |
|---|---|---|
| 5 | 1 | 2023-02-28 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 5 |
Manufacturing and distribution sites (5)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Kedrion S.p.A. | Bolognana, IT | FDA | |
| Kedrion S.p.A. | Naples, IT | EMA | |
| Kedrion S.p.A. | Gallicano, IT | EMA, Health Canada | |
| KEDRION S.P.A. | Barga (Castelvecchio Pascoli) Lucca, IT | FDA | |
| Kedrion S.p.A. | Barga, IT | EMA |
Latest dated events (20)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-08-13 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-04-30 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 20 events.
Biomarker capability evidence (39)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| GAD2 | Trial sponsor | Named in trial inclusion criteria |
| SEPHS1 | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 39 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 recalls, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.