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Megace

(Megestrol)

PreclinicalSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

1

Indications

5

Total Trials

0

Active Trials

0

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Megestrol AcetateCompleted

Megestrol AcetatePreclinical

Completed

Clinical

Trials by Indication[1]

Children1 trial

Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

Completed·—·Phase 2·NCT01206478·21 enrolled

Anorexia1 trial

Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.

Completed·UUniversity of Sao Paulo·Phase 2·NCT03283488·52 enrolled

Megestrol Acetate1 trial

Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00004664·69 enrolled

Nausea and vomiting1 trial

the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

Unknown status·HHenan Cancer Hospital·Phase 2·NCT04430361·120 enrolled

Unspecified1 trial

A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Completed·CCentre Oscar Lambret·Phase 2·NCT00420563·88 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MEGACE

NDA NDA016979

Sep 10, 1993

MEGACE

NDA NDA020264

Jul 5, 2005

MEGACE ES

NDA NDA021778

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Megestrol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Megestrol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Megestrol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021778). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

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