Organization (Industry)
Padagis LLC (United States)
ClinicalTrials.gov lists Padagis LLC (United States) as lead sponsor of 37 trials. It has 13 active development programs and 8 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 0.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Padagis LLC (United States): 37 lead-sponsored trials and 1 legal-entity registration.
Disease areas (17)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Acne Vulgaris | 6 |
| Rosacea | 4 |
| Candidiasis | 2 |
| Candidiasis, Vulvovaginal | 2 |
| Crohn Disease | 2 |
Showing 5 of 17 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 |
|---|---|
| 2023 | 1 |
| 2021 | 1 |
| 2019 | 2 |
| 2017 | 2 |
| 2016 | 3 |
| 2015 | 4 |
| 2014 | 2 |
| 2012 | 2 |
| 2011 | 3 |
| 2009 | 1 |
Showing 10 of 16 years.
Recruitment duration, a model prediction: none of the 37 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (13)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Simbrinza 0.2%-1% Ophthalmic Suspension | Glaucoma | Phase 3 | 1 |
| Simbrinza 0.2%-1% Ophthalmic Suspension | Glaucoma, Open-Angle | Phase 3 | 1 |
| Brinzolamide/brimonidine ophthalmic suspension | Glaucoma | Phase 3 | 1 |
| Brinzolamide/brimonidine ophthalmic suspension | Glaucoma, Open-Angle | Phase 3 | 1 |
| Brinzolamide 1% ophthalmic suspension | Glaucoma | Phase 3 | 1 |
Showing 5 of 13 active programs.
Approved assets (8)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Budesonide | 3 |
| Ingenol Mebutate | 2 |
| MOMETASONE FUROATE | 1 |
| Oxymetazoline | 1 |
| Mupirocin | 1 |
Showing 5 of 8 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 |
|---|---|
| 60% hit target (n=5) | 60% on time (n=5) |
Journals published in (1)
| Journal | Publications |
|---|---|
| Current medical research and opinion | 1 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 11 |
FDA recalls (8)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35 | Class II | 2026-06-23 |
| Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 | Class II | 2025-02-06 |
| Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05 | Class III | 2024-10-11 |
| Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30 | Class II | 2023-11-01 |
| Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01 | Class II | 2023-09-28 |
Showing 5 of 8 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 4 | 2017-03-01 |
Latest dated events (57)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-06-23 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-04-08 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-02-06 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2024-10-11 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2024-09-06 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 57 events.
Biomarker capability evidence (5)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CEACAM5 | Trial sponsor | Named in trial inclusion criteria |
| CEACAM5 | Trial sponsor | Named in trial inclusion criteria |
| CEACAM5 | Trial sponsor | Primary endpoint in a Phase 3 trial |
| CEACAM5 | Trial sponsor | Mentioned in trial text |
| CEACAM5 | Trial sponsor | Mentioned in trial text |
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, us granted patents, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.