Organization (Industry)
FAES FARMA SA
ClinicalTrials.gov lists FAES FARMA SA as lead sponsor of 17 trials. It has 18 active development programs and 7 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 0.4 trial starts a year over the five years to September, under the 5 a year the method needs.
Logo Faes Farma S.A., via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers FAES FARMA SA: 17 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (26)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Rhinitis, Allergic | 8 |
| Rhinitis, Allergic, Seasonal | 7 |
| Conjunctivitis, Allergic | 4 |
| Airway Obstruction | 3 |
| Nasal Obstruction | 3 |
Showing 5 of 26 disease areas.
Trials by start year as sponsor or collaborator (12)
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 |
|---|---|
| 2024 | 1 |
| 2023 | 1 |
| 2021 | 1 |
| 2020 | 2 |
| 2018 | 1 |
| 2017 | 1 |
| 2010 | 3 |
| 2007 | 3 |
| 2006 | 3 |
| 2005 | 1 |
Showing 10 of 12 years.
Recruitment duration, a model prediction: none of the 17 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (18)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Bilastine | Conjunctivitis, Allergic | Phase 3 | 2 |
| Hemorrane | Hemorrhoids | Phase 3 | 1 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Conjunctivitis, Allergic | Phase 3 | 1 |
| Hemorrane plus | Hemorrhoids | Phase 3 | 1 |
| Vehicle of Bilastine Ophthalmic Solution | Conjunctivitis, Allergic | Phase 3 | 1 |
Showing 5 of 18 active programs.
Approved assets (7)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Bilastine | 11 |
| Cetirizine | 3 |
| Mesalamine | 1 |
| Desloratadine | 1 |
| LEVOCETIRIZINE | 1 |
Showing 5 of 7 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 |
|---|---|
| 1 of 4 hit target (n=4) | 1 of 4 on time (n=4) |
Journals published in (12)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Drug and chemical toxicology | 3 |
| Allergy | 2 |
| Clinical drug investigation | 2 |
| Current medical research and opinion | 2 |
| Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology | 1 |
Showing 5 of 12 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 |
|---|---|---|
| 9 | 4 | 2025-12-09 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 2 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 8 | 2026-06-07 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Faes Farma, SA | Leioa, ES | EMA, FDA, Health Canada | |
| Faes Farma, SA | Derio, ES | EMA, FDA, Health Canada |
Organization relationships (3)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Dynamic Solutions | Co sponsors trial with | 1 |
| Maimónides Biomedical Research Institute of Córdoba | Co sponsors trial with | 1 |
| Charite University, Berlin, Germany | Co sponsors trial with | 1 |
Latest dated events (38)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-06-07 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-03 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-09 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-10-27 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2024-06-24 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 38 events.
Biomarker capability evidence (15)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| SLC25A20 | Trial sponsor | Primary endpoint in a Phase 3 trial |
| BCHE | Trial sponsor | Named in trial exclusion criteria |
| CYB5A | Trial sponsor | Named in trial exclusion criteria |
| CYB5R3 | Trial sponsor | Named in trial exclusion criteria |
| GPT | Trial collaborator | Named in trial exclusion criteria |
Showing 5 of 15 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, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.