oxandrolone
Trade name: oxandrin
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
Earliest trial started Dec 11, 1992 (NCT00001343)
Timeline
1960s
- Jul 21, 1964
Gemini Labs Llc — Earliest FDA Approval
- Jul 21, 1964
Gemini Labs Llc — NDA Secondary Org
- Jul 21, 1964
Gemini Labs Llc — NDA Organization
1990s
- Jan 1, 1992
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
- Dec 1, 2006
Sandoz — Marketing Organization
- Dec 1, 2006
Upsher-Smith Laboratories — Marketing Organization
- Dec 1, 2006
Novartis — Marketing Organization
- Jun 22, 2007
Par Pharmaceuticals — Marketing Organization
- Jul 10, 2007
Roxane Laboratories — Marketing Organization
- Jul 10, 2007
Boehringer Ingelheim — Marketing Organization
Indications
Approved for
Studied for
- Anemia · Phase 2
- Anterior Cruciate Ligament Injuries · Phase 2
- Biological Availability · Phase 1
- Body Weight · Phase 3
- Burns · Phase 2/Phase 3
- Drugs, Generic · Phase 1
- Dwarfism · Phase 2
- Fanconi Anemia · Phase 1
- Heart Defects, Congenital · Phase 1/Phase 2
- Heart Diseases · Phase 1/Phase 2
- HIV Wasting Syndrome · Phase 4
- Iron Deficiencies · Phase 2
- Klinefelter Syndrome · Phase 2
- Knee · Phase 4
- Malnutrition · Phase 1
- Neoplasms · Phase 3
- Pressure Ulcer · Phase 3
- Rotator Cuff Injuries · Phase 2
- Traumatology · Phase 3
- Turner Syndrome · Phase 2
- Wounds and Injuries · Phase 2
Mechanism of action
- Androgen ReceptorAGONIST
AR agonist
Approval history
- approvedJul 21, 1964
Chemistry & pharmacology
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
Sources
- WikipediaOxandrolone ↗
- NCATS7H6TM3CT4L ↗
- ChEMBLCHEMBL1200436 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06974526 | Phase 2 | Jun 16, 2025 | Science Valley Research Institute |
| NCT05893069 | Phase 4 | Jul 1, 2023 | University of Southern California |
| NCT05516849 | Phase 3 | Aug 15, 2022 | Department of Defense, United States Army, University of Toronto |
| NCT04090697 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2019 | Cook Children's Medical Center, New England Research Institutes, University of Utah |
| NCT03218631 | Phase 1 | Jul 10, 2017 | University of Utah |
| NCT03091075 | Phase 2 | Jun 1, 2017 | University of Southern California |
| NCT02047552 | Phase 2 | Jan 1, 2015 | University of Colorado, University of Colorado, Denver |
| NCT01048632 | Phase 1 | Jul 1, 2010 | University of Utah |
| NCT00348946 | Phase 2 | Jul 1, 2006 | National Institute of Neurological Disorders and Stroke (NINDS), Thomas Jefferson University |
| NCT00101361 | Phase 3 | Aug 1, 2005 | Department of Veteran Affairs |
| NCT00652886 | Phase 1 | Mar 1, 2005 | Par Pharmaceuticals, PRACS |
| NCT00243399 | Phase 1 | Jul 1, 2004 | Food and Drug Administration, University of Cincinnati |
| NCT00070148 | Phase 3 | Mar 1, 2004 | National Cancer Institute (NCI), Wake Forest University |
| NCT00675714 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2004 | Department of Education, National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), The University of Texas, Dallas, University of Texas, Galveston |
| NCT00223769 | N/A | Jan 1, 2004 | Department of Veteran Affairs |
| NCT00673309 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2002 | National Institutes of Health (NIH), The University of Texas, Dallas, University of Texas, Galveston |
| NCT00027391 | N/A | Sep 1, 2001 | Food and Drug Administration, Ohio State University |
| NCT00004275 | Phase 2 | Oct 1, 1999 | National Institute of Neurological Disorders and Stroke (NINDS), Thomas Jefferson University |
| NCT00006167 | Phase 4 | Jan 1, 1998 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts University |
| NCT00001343 | Phase 2 | Dec 11, 1992 | National Institutes of Health (NIH) |
Organizations
Research & Development (27)
Marketing (8)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Boehringer Ingelheim | For profit | MKTG | Jul 10, 2007 |
| Gemini Labs Llc | For profit | NDA2 | Jul 21, 1964 |
| Gemini Labs Llc | For profit | NDA | Jul 21, 1964 |
| Novartis | For profit | MKTG | Dec 1, 2006 |
| Par Pharmaceuticals | For profit | MKTG | Jun 22, 2007 |
| Roxane Laboratories | For profit | MKTG | Jul 10, 2007 |
| Sandoz | For profit | MKTG | Dec 1, 2006 |
| Upsher-Smith Laboratories | For profit | MKTG | Dec 1, 2006 |