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Organization (Industry)

Mallinckrodt (Ireland)

ClinicalTrials.gov lists Mallinckrodt (Ireland) as lead sponsor of 87 trials. It has 18 approved assets.

IE Industry
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16 0 1998 2026

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 1.6 trial starts a year over the five years to September, under the 5 a year the method needs.

This page covers Mallinckrodt (Ireland): 87 lead-sponsored trials and 4 legal-entity registrations.

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Disease areas (132)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Pain 28
Multiple Sclerosis 11
Postoperative Pain 11
Hypertension, Pulmonary 10
Arthritis, Rheumatoid 8

Trials by start year as sponsor or collaborator (28)

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
Trials by start year as sponsor or collaborator
Year Trials started
2026 (partial year) 1
2025 1
2024 1
2023 1
2022 2
2021 6
2020 1
2019 9
2018 12
2017 14

Recruitment duration, a model prediction: none of the 87 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Approved assets (18)

Shown in this order: max phase first.

Approved assets
Drug Trials
IV Acetaminophen 10
ACTHAR Gel (ACTH) 8
Oral Acetaminophen 3
Repository Corticotropin Injection 3
MORPHINE 2

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.

Sponsor delivery record
Enrollment Timeline
50% hit target (n=14) 54% on time (n=13)

Journals published in (188)

Shown in this order: most published in first.

Journals published in
Journal Publications
Pediatrics 13
The New England journal of medicine 8
Ophthalmology 7
The Journal of pediatrics 7
The Journal of thoracic and cardiovascular surgery 7

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 granted patents
US patents granted Granted in the last 5 years Most recent grant
716 1 2021-10-12

FDA recalls (8)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007 Class II 2022-06-23
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60 Class II 2019-05-13
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60 Class II 2019-05-13
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04 Class II 2015-05-15
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134 Class III 2012-07-30

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
1 2002-01-02

Manufacturing and distribution sites (2)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
Curium US LLC Maryland Heights, US FDA, Health Canada
Mallinckrodt Inc. St. Louis, US Health Canada

Organization relationships (57)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
The Cleveland Clinic Co sponsors trial with 3
M.D. Anderson Cancer Center Co sponsors trial with 2
University of Colorado System Co sponsors trial with 2
University of California System Co sponsors trial with 1
Canadian Institutes of Health Research Co sponsors trial with 1

Latest dated events (918)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-06-01 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2025-05-14 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2024-02 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2023-01-10 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2022-11-03 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))

Biomarker capability evidence (230)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
ACE Trial collaborator Named in trial inclusion criteria
AGT Trial collaborator Named in trial inclusion criteria
AGT Trial collaborator Named in trial inclusion criteria
ALB Trial sponsor Named in trial inclusion criteria
ALB Trial sponsor Named in trial inclusion criteria

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, fda inspection record, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.