Organization (Industry)
SEPTODONT HOLDING
ClinicalTrials.gov lists SEPTODONT HOLDING as lead sponsor of 11 trials, counting the companies grouped under it. SEPTODONT HOLDING itself has 3 active development programs.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. Companies grouped under this one are not included. 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 1.4 trial starts a year over the five years to September, under the 5 a year the method needs.
Logo Septodont, via Wikimedia Commons, CC BY-SA 4.0. Shown to identify the organization; it may be a registered trademark.
This page covers SEPTODONT HOLDING and 1 company grouped under it: 11 lead-sponsored trials (11 its own, 0 in the grouped companies) and 4 legal-entity registrations (3 its own, 1 in the grouped companies).
Companies grouped under this page (1)
| Company | Lead trials | Legal entities |
|---|---|---|
| LABORATORIOS INIBSA S.A. | 0 | 1 |
Disease areas (9)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Dental Pulp Diseases | 1 |
| Dry Socket | 1 |
| Hemorrhage | 1 |
| Malocclusion | 1 |
| Mouth, Edentulous | 1 |
Showing 5 of 9 disease areas.
Trials by start year as sponsor or collaborator (6)
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 |
| 2022 | 3 |
| 2021 | 6 |
| 2020 | 1 |
| 2014 | 1 |
Recruitment duration, a model prediction: none of the 11 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (3)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Biodentine | Dental Pulp Diseases | Not reported | 1 |
| Biodentine | Tooth, Nonvital | Not reported | 1 |
| Alveogyl | Dry Socket | Not reported | 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 |
|---|---|
| 86% hit target (n=7) | 17% on time (n=6) |
Journals published in (8)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| International endodontic journal | 5 |
| Journal of endodontics | 4 |
| Journal of dentistry | 3 |
| Dental materials : official publication of the Academy of Dental Materials | 1 |
| Endodontics & dental traumatology | 1 |
Showing 5 of 8 journals.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 4 |
FDA recalls (2)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116 | Class II | 2019-05-02 |
| OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10 | Class III | 2018-04-13 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 5 | 2026-08-14 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Laboratorios Inibsa S.A. | Llica De Vall, ES | EMA, Health Canada | Laboratorios Inibsa S.A. |
| Septodont, Inc | Lancaster, US | FDA | Septodont, Inc |
Latest dated events (24)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-08-14 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-10-23 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-04-16 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2024-02-09 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2023-05-25 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 24 events.
Not on this page
Checked, with nothing recorded for this organization: related companies not grouped here, approved assets, us granted patents, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, biomarker capability evidence, and biomarkers this organization publishes on.