Organization (Industry)
Dr. Falk Pharma GmbH
ClinicalTrials.gov lists Dr. Falk Pharma GmbH as lead sponsor of 39 trials. It has 15 active development programs and 6 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: 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 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Dr. Falk Pharma GmbH: 39 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (34)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Inflammatory Bowel Diseases | 11 |
| Colitis, Ulcerative | 7 |
| Eosinophilic Esophagitis | 5 |
| Esophagitis | 5 |
| Colitis, Microscopic | 4 |
Showing 5 of 34 disease areas.
Trials by start year as sponsor or collaborator (22)
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 |
|---|---|
| 2025 | 1 |
| 2024 | 1 |
| 2023 | 2 |
| 2022 | 1 |
| 2021 | 1 |
| 2019 | 2 |
| 2018 | 1 |
| 2016 | 1 |
| 2015 | 2 |
| 2014 | 3 |
Showing 10 of 22 years.
Recruitment duration, a model prediction: none of the 39 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (15)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| norUrsodeoxycholic Acid | Cholangitis, Sclerosing | Phase 3 | 2 |
| norUrsodeoxycholic Acid | Cholangitis | Phase 3 | 2 |
| Budesonide | Eosinophilic Esophagitis | Phase 3 | 1 |
| Budesonide | Esophagitis | Phase 3 | 1 |
| ZED1227 + SIGE | Celiac Disease | Phase 2 | 1 |
Showing 5 of 15 active programs.
Approved assets (6)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Ursodeoxycholic Acid | 2 |
| Budesonide | 12 |
| Mesalamine | 10 |
| Ciprofloxacin | 1 |
| AZATHIOPRINE | 1 |
Showing 5 of 6 approved assets.
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 |
|---|---|
| 67% hit target (n=6) | 43% on time (n=7) |
Journals published in (18)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Gastroenterology | 7 |
| Alimentary pharmacology & therapeutics | 6 |
| Gut | 6 |
| Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association | 3 |
| Journal of hepatology | 3 |
Showing 5 of 18 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 |
|---|---|---|
| 31 | 9 | 2025-11-18 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Dr. Falk Pharma GmbH | Freiburg Im Breisgau, DE | EMA, Health Canada |
Organization relationships (4)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Takeda Development Center Americas, Inc. | Co sponsors trial with | 1 |
| Rafa Laboratories | Co sponsors trial with | 1 |
| The Swedish Organization for Studies on Inflammatory Bowel Disease | Co sponsors trial with | 1 |
| Sublimity Therapeutics Holdco Limited | Co sponsors trial with | 1 |
Latest dated events (78)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-11-18 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-11-04 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-03 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-08-20 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2024-06-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 78 events.
Biomarker capability evidence (60)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| AGT | Trial collaborator | Named in trial inclusion criteria |
| ATP12A | Trial sponsor | Named in trial inclusion criteria |
| ATP12A | Trial sponsor | Named in trial inclusion criteria |
| ATP4A | Trial sponsor | Named in trial inclusion criteria |
| ATP4A | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 60 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, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.