Organization (Other)
LABORATORIOS SILANES, S.A. DE C.V.
ClinicalTrials.gov lists LABORATORIOS SILANES, S.A. DE C.V. as lead sponsor of 44 trials. It has 77 active development programs and 14 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 3.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers LABORATORIOS SILANES, S.A. DE C.V.: 44 lead-sponsored trials and 1 legal-entity registration.
Disease areas (34)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Diabetes Mellitus | 11 |
| Pain | 10 |
| Diabetes Mellitus, Type 2 | 9 |
| Acute Pain | 4 |
| Back Pain | 3 |
Showing 5 of 34 disease areas.
Trials by start year as sponsor or collaborator (16)
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 | 3 |
| 2024 | 6 |
| 2023 | 1 |
| 2022 | 4 |
| 2021 | 7 |
| 2020 | 2 |
| 2019 | 4 |
| 2018 | 1 |
| 2017 | 1 |
| 2015 | 1 |
Showing 10 of 16 years.
Recruitment duration, a model prediction: 2 trials 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 (77)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Celecoxib + Acetaminohen | Pain | Phase 3 | 1 |
| Celecoxib + Acetaminohen | Osteoarthritis, Hip | Phase 3 | 1 |
| Celecoxib + Acetaminohen | Arthralgia | Phase 3 | 1 |
| Celecoxib + Acetaminohen | Osteoarthritis, Knee | Phase 3 | 1 |
| Celecoxib + Acetaminohen | Osteoarthritis | Phase 3 | 1 |
Showing 5 of 77 active programs.
Approved assets (14)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| METFORMIN | 9 |
| GLIMEPIRIDE + METFORMIN | 1 |
| GLIMEPIRIDE | 1 |
| metformin/glimepiride combination | 1 |
| Dexketoprofen | 1 |
Showing 5 of 14 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=12) | 36% on time (n=11) |
Journals published in (242)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Diabetes care | 16 |
| The New England journal of medicine | 11 |
| Diabetes, obesity & metabolism | 9 |
| Lancet (London, England) | 8 |
| Clinical therapeutics | 7 |
Showing 5 of 242 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 | 3 | 2024-04-09 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 9 | 2025-05-14 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Laboratorios Silanes, S.A. de C.V. | Toluca, MX | FDA |
Latest dated events (61)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-05-14 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-05-14 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-01-27 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-01-13 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-11-11 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 61 events.
Biomarker capability evidence (92)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ALB | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial inclusion criteria |
| CLU | Trial sponsor | Named in trial inclusion criteria |
| CLU | Trial sponsor | Named in trial inclusion criteria |
| DPP4 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 92 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, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.