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Organization (Industry)

EMD Serono, Inc. (United States)

ClinicalTrials.gov lists EMD Serono, Inc. (United States) as lead sponsor of 91 trials. It has 25 approved assets.

US Industry Manufacturer
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14 0 1997 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 1.2 trial starts a year over the five years to September, under the 5 a year the method needs.

Logo Unknown author Unknown author (Merck KGaA), via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers EMD Serono, Inc. (United States): 91 lead-sponsored trials and 2 legal-entity registrations. The parent company on record for EMD Serono, Inc. (United States) is Merck KGaA, Darmstadt (Germany), which does not have its own page on this site.

Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.

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Disease areas (67)

Shown in this order: most trials first (counted at this company's own legal-entity record, not the consolidated group).

Trials by start year as sponsor or collaborator (27)

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
2024 4
2023 1
2021 3
2020 3
2019 8
2018 5
2017 5
2016 3
2015 2

Recruitment duration, a model prediction: none of the 91 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Approved assets (25)

Shown in this order: max phase first.

Approved assets
Drug Trials
Interferon Beta-1A 8
rFSH 2
Recombinant Human Choriogonadotropin (r-hCG) 2
Antagon ™ 1
Luveris® 25 IU 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.

Sponsor delivery record
Enrollment Timeline
not enough data 1 of 2 on time (n=2)

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
VAI 5

FDA recalls (2)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1 Class II 2020-06-29
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7. Class III 2015-09-10

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
7 2026-04-14

Manufacturing and distribution sites (1)

Manufacturing and distribution sites
Facility Location Regulators Member organization
EMD Serono, Inc. Boston, US FDA

Biomarker capability evidence (465)

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

Biomarker capability evidence
Gene Role Evidence
AKT1 Trial sponsor Named in trial inclusion criteria
ALB Trial collaborator Named in trial inclusion criteria
ALK Trial collaborator Named in trial inclusion criteria
ALPK1 Trial collaborator Named in trial inclusion criteria
ARID1A Trial collaborator Named in trial inclusion criteria

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, 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, and clia clinical laboratory certificates.

Counted at group level under Merck KGaA, Darmstadt (Germany): journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.