Oxandrolone

Phase 2Small molecule

PPar Pharmaceutical, Inc.

Oxandrolone is one of 94 small molecule programs targeting Facioscapulohumeral dystrophy. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Facioscapulohumeral DystrophyActive, not recruiting

Spinal Cord InjuryActive, not recruiting

Anterior Cruciate Ligament (ACL)Recruiting

TrialActive, not recruiting

Facioscapulohumeral DystrophyPreclinical

Active, not recruiting

Spinal Cord InjuryPreclinical

Active, not recruiting

Anterior Cruciate Ligament (ACL)Phase 2

Recruiting

TrialPreclinical

Active, not recruiting

Competition

Competitive Landscape

139 competitors in Trial

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

4 2

Yervoy

Bristol-Myers Squibb

Phase 3

3 3

Vectibix

Amgen

Phase 3

2 4

Camptosar

Pfizer

Phase 3

2 5

Eloxatin

Teva

Phase 3

2 6

Perjeta

Roche

Phase 3

2 7

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

5 8

Tarceva

OOSI Pharmaceuticals

Phase 3

5 9

Herceptin

OOrganon and Co

Phase 3

4 10

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Anterior Cruciate Ligament (ACL)

NCT06974526

Clinical

Trials by Indication[1]

Growth2 trials

Use of Oxandrolone to Promote Growth in Infants With HLHS

Terminated·CCarelon Research·Phase 1/2·NCT04090697·34 enrolled

Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00004275·80 enrolled

Spinal Cord Injury1 trial

The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury

Completed·UUS Department of Veterans Affairs·N/A·NCT00223769·40 enrolled

Trauma1 trial

Placebo Versus Oxandrolone Supplementation in Trauma

Withdrawn·SSunnybrook Health Sciences Centre·Phase 3·NCT05516849

AIDS1 trial

Nutrition Intervention in AIDS Wasting

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 4·NCT00006167

Fanconi Anemia1 trial

Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia

Completed·—·Phase 1·NCT00243399·10 enrolled

12 more indications

Fasting Conditions1 trial

Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00652886·26 enrolled

Turner syndrome1 trial

The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00001343·80 enrolled

Pressure Ulcers1 trial

Oxandrolone to Heal Pressure Ulcers

Terminated·UUS Department of Veterans Affairs·Phase 3·NCT00101361·212 enrolled

Weight loss1 trial

Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer

Completed·WWake Forest University Health Sciences·Phase 3·NCT00070148·155 enrolled

Trial1 trial

Oxandrolone Rotator Cuff Trial

Active, not recruiting·UUniversity of Southern California·N/A·NCT03091075·116 enrolled

Rehabilitation1 trial

Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT00675714·1,126 enrolled

Malnutrition1 trial

Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants

Completed·UUniversity of Utah·Phase 1·NCT01048632·20 enrolled

Facioscapulohumeral dystrophy1 trial

Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)

Completed·FFDA Office of Orphan Products Development·N/A·NCT00027391·160 enrolled

Critically Ill1 trial

RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone

Withdrawn·—·Phase 2·NCT02047552

Wound Healing1 trial

Assessment of Mechanisms of Improved Wound Healing

Completed·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT00673309·644 enrolled

Anterior Cruciate Ligament (ACL)1 trial

Randomized, Multicenter, Double-blind, Parallel, Placebo-controlled Study to Investigate the Safety and Exploratory Efficacy of the Oxandrolone Subdermal Bioabsorbable Implant as an Adjuvant Treatment in Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction (IMOX Study)

Recruiting·SScience Valley Research Institute·Phase 2·NCT06974526·96 enrolled

Unspecified1 trial

Oxandrolone Multiligament Knee

Suspended·—·Phase 4·NCT05893069·60 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Oxandrolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oxandrolone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oxandrolone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Par Pharmaceutical, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: PPar Pharmaceutical, Inc.

Oxandrolone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Growth2 trials

Spinal Cord Injury1 trial

Trauma1 trial

AIDS1 trial

Fanconi Anemia1 trial

Fasting Conditions1 trial

Turner syndrome1 trial

Pressure Ulcers1 trial

Weight loss1 trial

Trial1 trial

Rehabilitation1 trial

Malnutrition1 trial

Facioscapulohumeral dystrophy1 trial

Critically Ill1 trial

Wound Healing1 trial

Anterior Cruciate Ligament (ACL)1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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