Organization (Industry)
candela gmbh
ClinicalTrials.gov lists candela gmbh as lead sponsor of 19 trials. It has 1 approved asset.
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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: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 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.
This page covers candela gmbh: 19 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (20)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Cutis Laxa | 4 |
| Acne Vulgaris | 3 |
| Port-Wine Stain | 3 |
| Rosacea | 2 |
| Breast Neoplasms | 1 |
Showing 5 of 20 disease areas.
Trials by start year as sponsor or collaborator (17)
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 |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 1 |
| 2024 | 1 |
| 2023 | 3 |
| 2022 | 1 |
| 2021 | 1 |
| 2020 | 5 |
| 2019 | 3 |
| 2018 | 3 |
| 2017 | 1 |
Showing 10 of 17 years.
Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Approved assets (1)
| Drug | Trials |
|---|---|
| Oxymetazoline HCL 1% Cream | 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 |
|---|---|
| 0% hit target (n=6) | 50% on time (n=6) |
Journals published in (30)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| American journal of obstetrics and gynecology | 4 |
| Lasers in surgery and medicine | 4 |
| Climacteric : the journal of the International Menopause Society | 3 |
| Journal of the American Academy of Dermatology | 3 |
| Lasers in medical science | 3 |
Showing 5 of 30 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 |
|---|---|---|
| 61 | 9 | 2025-10-28 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 4 |
FDA recalls (5)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. | Class II | 2019-09-10 |
| Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser. | Class II | 2019-09-10 |
| Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser. | Class II | 2019-09-10 |
| Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser. | Class II | 2019-09-10 |
| Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040 | Class II | 2013-11-06 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 4 | 2026-06-11 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Candela Corporation | Marlborough, US | FDA |
Latest dated events (101)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-06-11 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-10-28 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-06-17 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-04-29 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 101 events.
Biomarker capability evidence (8)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CEACAM5 | Trial sponsor | Named in trial inclusion criteria |
| FST | Trial sponsor | Named in trial inclusion criteria |
| HMGXB3 | Trial sponsor | Named in trial exclusion criteria |
| PHLDA2 | Trial sponsor | Named in trial exclusion criteria |
| CEACAM5 | Trial sponsor | Mentioned in trial text |
Showing 5 of 8 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, 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, and biomarkers this organization publishes on.