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Oxandrin (OXANDROLONE)
Oxandrin (oxandrolone) is a small molecule anabolic steroid that targets the androgen receptor. It was originally developed by CREALTA PHARMS LLC in 1964 and is currently owned by the same company. Oxandrin is used to treat catabolic processes and has a bioavailability of 97% with a half-life of 13.3 hours. The drug is off-patent and has multiple generic manufacturers. Key safety considerations include its potential for liver toxicity and cardiovascular side effects.
At a glance
| Generic name | OXANDROLONE |
|---|---|
| Sponsor | Crealta Pharms Llc |
| Drug class | oxandrolone |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 1964 |
Approved indications
- Catabolic Process
Common side effects
- Acne
- Edema
- Gynecomastia
- Menstrual irregularities
- Clitoral enlargement
- Phallic enlargement
- Increased frequency or persistence of erections
- Hirsutism
- Male pattern baldness in females
- Deepening of the voice in females
- Insomnia
- Depression
Serious adverse events
- Cholestatic jaundice with hepatic necrosis and death
- Hepatocellular neoplasms
- Peliosis hepatis
- Testicular atrophy
- Oligospermia
- Chronic priapism
- Premature closure of epiphyses in children
- Bleeding in patients on concomitant anticoagulant therapy
- Masculinization of the fetus
- Inhibition of testicular function
Drug interactions
- warfarin
Key clinical trials
- Oxandrolone Multiligament Knee (PHASE4)
- Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction (PHASE2)
- Oxandrolone Rotator Cuff Trial (NA)
- Use of Oxandrolone to Promote Growth in Infants With HLHS (PHASE1,PHASE2)
- Placebo Versus Oxandrolone Supplementation in Trauma (PHASE3)
- Assessment of Mechanisms of Improved Wound Healing (PHASE2,PHASE3)
- Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer (PHASE3)
- Androgen Effect on Klinefelter Syndrome Motor Outcome (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oxandrin CI brief — competitive landscape report
- Oxandrin updates RSS · CI watch RSS
- Crealta Pharms Llc portfolio CI