oxandrolone

Trade name: oxandrin

Small moleculeapproved

Approved

Jul 21, 1964

Oxandrolone is a synthetic, orally active anabolic-androgenic steroid. Oxandrolones interact with androgen receptors in target tissues. Oxandrin is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis. Side effects include: elevated aminotransferases (ALT, AST), lipid abnormalities (e.g., decreased HDL cholesterol concentrations). Cardiovascular side effects have included edema, with and without congestive heart failure. Oxandrolone may inhibit the metabolism of oral hypoglycemic agents. In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema. — NCATS

Clinical trial activity

20 trials · 27 clinical orgs · 7 marketing orgs

Phase 1
5
Phase 2
10
Phase 3
5
Phase 4
2

Earliest trial started Dec 11, 1992 (NCT00001343)

Timeline

1960s

  1. Jul 21, 1964

    Gemini Labs Llc — Earliest FDA Approval

  2. Jul 21, 1964

    Gemini Labs Llc — NDA Secondary Org

  3. Jul 21, 1964

    Gemini Labs Llc — NDA Organization

1990s

  1. Jan 1, 1992

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  3. Dec 1, 2006

    Sandoz — Marketing Organization

  4. Dec 1, 2006

    Upsher-Smith Laboratories — Marketing Organization

  5. Dec 1, 2006

    Novartis — Marketing Organization

  6. Jun 22, 2007

    Par Pharmaceuticals — Marketing Organization

  7. Jul 10, 2007

    Roxane Laboratories — Marketing Organization

  8. Jul 10, 2007

    Boehringer Ingelheim — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJul 21, 1964

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]1(O)CC[C@H]2[C@@H]3CC[C@H]4CC(=O)OC[C@]4(C)[C@H]3CC[C@]12C
Mol. weight
306.4397 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • anavar
  • anavar
  • anavar
  • lonavar
  • ossandrolone
  • ossandrolone
  • oxandren
  • oxandrin
  • oxandrin
  • oxandrin
  • oxandrin
  • oxandrin
  • oxandrolon
  • oxandrolon
  • oxandrolona
  • oxandrolona
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolone
  • oxandrolonum
  • oxandrolonum
  • protivar
  • protivar
  • sc-11585
  • sc-11585
  • vasorome

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06974526Phase 2Jun 16, 2025Science Valley Research Institute
NCT05893069Phase 4Jul 1, 2023University of Southern California
NCT05516849Phase 3Aug 15, 2022Department of Defense, United States Army, University of Toronto
NCT04090697Phase 1/Phase 2 (Phase 2)Nov 1, 2019Cook Children's Medical Center, New England Research Institutes, University of Utah
NCT03218631Phase 1Jul 10, 2017University of Utah
NCT03091075Phase 2Jun 1, 2017University of Southern California
NCT02047552Phase 2Jan 1, 2015University of Colorado, University of Colorado, Denver
NCT01048632Phase 1Jul 1, 2010University of Utah
NCT00348946Phase 2Jul 1, 2006National Institute of Neurological Disorders and Stroke (NINDS), Thomas Jefferson University
NCT00101361Phase 3Aug 1, 2005Department of Veteran Affairs
NCT00652886Phase 1Mar 1, 2005Par Pharmaceuticals, PRACS
NCT00243399Phase 1Jul 1, 2004Food and Drug Administration, University of Cincinnati
NCT00070148Phase 3Mar 1, 2004National Cancer Institute (NCI), Wake Forest University
NCT00675714Phase 2/Phase 3 (Phase 3)Jan 1, 2004Department of Education, National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), The University of Texas, Dallas, University of Texas, Galveston
NCT00223769N/AJan 1, 2004Department of Veteran Affairs
NCT00673309Phase 2/Phase 3 (Phase 3)Jul 1, 2002National Institutes of Health (NIH), The University of Texas, Dallas, University of Texas, Galveston
NCT00027391N/ASep 1, 2001Food and Drug Administration, Ohio State University
NCT00004275Phase 2Oct 1, 1999National Institute of Neurological Disorders and Stroke (NINDS), Thomas Jefferson University
NCT00006167Phase 4Jan 1, 1998National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts University
NCT00001343Phase 2Dec 11, 1992National Institutes of Health (NIH)
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (27)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institutes of Health (NIH)Government3121992
University of UtahAcademic/Hospital3222010
Department of Veteran AffairsGovernment2222004
Food and Drug AdministrationGovernment2122001
National Institute of Neurological Disorders and Stroke (NINDS)Government2111999
The University of Texas, DallasAcademic/Hospital2012002
Thomas Jefferson UniversityAcademic/Hospital2111999
University of Southern CaliforniaAcademic/Hospital2222017
University of Texas, GalvestonAcademic/Hospital2212002
Cook Children's Medical CenterAcademic/Hospital1012019
Department of DefenseGovernment1012022
Department of EducationGovernment1012004
National Cancer Institute (NCI)Government1012004
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1111998
National Institute of General Medical Sciences (NIGMS)Government1012004
New England Research InstitutesFor profit1112019
Ohio State UniversityAcademic/Hospital1012001
Par PharmaceuticalsFor profit1112005
PRACSFor profit1012005
Science Valley Research InstituteFor profit1112025
27 organizations
Page 1 / 2

Marketing (8)

OrganizationOrg typeRelationshipDate
Boehringer IngelheimFor profitMKTGJul 10, 2007
Gemini Labs LlcFor profitNDA2Jul 21, 1964
Gemini Labs LlcFor profitNDAJul 21, 1964
NovartisFor profitMKTGDec 1, 2006
Par PharmaceuticalsFor profitMKTGJun 22, 2007
Roxane LaboratoriesFor profitMKTGJul 10, 2007
SandozFor profitMKTGDec 1, 2006
Upsher-Smith LaboratoriesFor profitMKTGDec 1, 2006