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Organization (Industry)

Gedeon Richter (Hungary)

ClinicalTrials.gov lists Gedeon Richter (Hungary) as lead sponsor of 12 trials. It has 24 active development programs and 6 approved assets.

HU Industry Manufacturer
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7 0 2007 2026

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 2.2 trial starts a year over the five years to September, under the 5 a year the method needs.

Logo Tothfanni gedeonrichter, via Wikimedia Commons, CC BY-SA 4.0. Shown to identify the organization; it may be a registered trademark.

This page covers Gedeon Richter (Hungary): 12 lead-sponsored trials and 2 legal-entity registrations.

Get the Gedeon Richter (Hungary) report as a PDF

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Disease areas (37)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Schizophrenia 7
Diabetes Mellitus 5
Bipolar Disorder 4
Major Depressive Disorder 4
Mania 4

Trials by start year as sponsor or collaborator (18)

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
Trials by start year as sponsor or collaborator
Year Trials started
2025 5
2024 3
2023 2
2022 1
2021 1
2020 1
2019 1
2018 1
2017 2
2015 2

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 (24)

Shown in this order: max phase, then active trials.

Active development programs
Drug Disease area Max phase Trials
Cariprazine Schizophrenia Phase 3 1
DENOSUMAB Bone Diseases, Metabolic Phase 3 1
RGB-14-P Bone Diseases, Metabolic Phase 3 1
RGB-14-P Osteoporosis Phase 3 1
RGB-14-P Osteoporosis, Postmenopausal Phase 3 1

Approved assets (6)

Shown in this order: max phase first.

Approved assets
Drug Trials
DENOSUMAB 1
Cariprazine 1
Teriparatide 1
RITUXIMAB 1
BACLOFEN 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.

Sponsor delivery record
Enrollment Timeline
3 of 4 hit target (n=4) 3 of 4 on time (n=4)

Journals published in (32)

Shown in this order: most published in first.

Journals published in
Journal Publications
Journal of affective disorders 6
The Journal of clinical psychiatry 5
Advances in therapy 2
Fertility and sterility 2
Hypertension (Dallas, Tex. : 1979) 2

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 granted patents
US patents granted Granted in the last 5 years Most recent grant
59 14 2025-11-18

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
NAI 6

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
32 2026-02-20

Manufacturing and distribution sites (5)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
Richter Gedeon Nyrt. Budapest, HU EMA, FDA
Gedeon Richter Plc. Vecses, HU EMA
Gedeon Richter Plc. Budapest X, HU EMA, Health Canada
Gedeon Richter Plc. Budapest X, HU EMA
Gedeon Richter Plc. Budapest X, HU EMA

Organization relationships (7)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Ghent University Hospital Co sponsors trial with 1
Antwerp University Hospital Co sponsors trial with 1
Forest Laboratories (United States) Co sponsors trial with 1
Ferring Pharmaceuticals (Switzerland) Co sponsors trial with 1
AZ Jan Palfijn Gent Co sponsors trial with 1

Latest dated events (136)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-02-20 FDA import refusal FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)
2025-11-18 Patent granted Granted US patents (PatentsView / USPTO)
2025-10-07 Patent granted Granted US patents (PatentsView / USPTO)
2025-08-05 FDA import refusal FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)
2025-07-29 Patent granted Granted US patents (PatentsView / USPTO)

Biomarker capability evidence (8)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
PRL Trial collaborator Primary endpoint in a Phase 3 trial
BRCA1 Trial collaborator Named in trial exclusion criteria
CSF3 Trial sponsor Named in trial exclusion criteria
NADK Trial collaborator Named in trial exclusion criteria
BRCA1 Trial collaborator Mentioned in trial text

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, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.