Delving into the Latest Updates on Organon USA, Inc. with Synapse

Overview

Tags

Urogenital Diseases

Other Diseases

Endocrinology and Metabolic Disease

Hormone

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	2

Top 5 Drug Type	Count

Hormone	2
Small molecule drug	1

Top 5 Target	Count

ADRA2(Adrenergic receptors alpha-2)	1
FSHR x LHCGR	1
FSHR(Follicle-stimulating hormone receptor)	1

Author: Griffin, Troy ; Nagao, Lee ; Stanard, Brad ; Johann, Esther ; Cruz, Maureen ; Martin, Elizabeth A. ; Masuda-Herrera, Melisa ; Bruen, Uma ; Whelan, Geraldine ; Callis, Courtney ; Bercu, Joel ; Kohan, Martin ; Graham, Jessica ; Tien, Eric ; Parris, Patricia ; Burild, Anders ; Whritenour, Jessica

During the toxicological assessment of extractables and leachables in drug products, localized hazards such as irritation or sensitization may be identified. Typically, because of the low concentration at which leachables occur in pharmaceuticals, irritation is of minimal concern; therefore, this manuscript focuses on sensitization potential. The primary objective of performing a leachable sensitization assessment is protection against Type IV induction of sensitization, rather than prevention of an elicitation response, as it is not possible to account for the immunological state of every individual. Sensitizers have a wide range of potencies and those which induce sensitization upon exposure at a low concentration (i.e. strong, or extreme sensitizers) pose the highest risk to patients and should be the focus of the risk assessment. The Extractables and Leachables Safety Information Exchange (ELSIE) consortium has reviewed the status of dermal, respiratory, and systemic risk assessment in cosmetic and pharmaceutical industries, and proposes a framework to evaluate the safety of known or potential dermal sensitizers in pharmaceuticals. Due to the lack of specific regulatory guidance on this topic, the science-driven risk-based approach proposed by ELSIE encourages consistency in the toxicological assessment of extractables and leachables to maintain high product quality and ensure patient safety.

08 Nov 2007·Journal of Biopharmaceutical Statistics

Guest-Editor's Note: “Statistical Issues in Adaptive Design Methods in Clinical Trials”

Author: Pong, Annpey

01 Nov 1998·Journal of Reproductive ImmunologyQ3 · MEDICINE

HIV and germinal cells: how close an association?

Q3 · MEDICINE

Review

Author: Alexander, N J

Whether semen from someone who is HIV-positive can be prepared so that it is safe for insemination is a critical question particularly to couples in which the male is seropositive and the female is seronegative. It is reassuring that some investigators have reported great success in using sperm washing to dramatically reduce HIV levels in the ejaculate. Such reports suggest that if free virus and leukocytes in the seminal plasma are removed, the specimen may be safe for insemination. Whether the virus ever is associated with spermatozoa themselves is not fully understood. In situ hybridization as well as electron microscopic studies have suggested the presence of viral particles but whether these are preparation artifacts or evidence of viable viral DNA is not known. Studies of whether the virus is incorporated into developing spermatozoa or is shed in the reproductive tract will aid in the elucidation of sexual transmission of HIV.

100 Deals associated with Organon USA, Inc.

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100 Translational Medicine associated with Organon USA, Inc.

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Pipeline

Pipeline Snapshot as of 26 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Approved

3

14

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Follitropin Beta ( FSHR )	Infertility More	Approved
Mirtazapine ( ADRA2 )	Depressive Disorder More	Approved
Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.) ( FSHR x LHCGR )	Hypogonadism More	Approved
Pipecuronium Bromide ( nAChRα1/β1/δ/γ )	Anesthesia More	Withdrawn
Ethinyl Estradiol ( ER )	Contraception More	Withdrawn