AVEED (testosterone undecanoate)
Aveed is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (testicular failure) and hypogonadotropic hypogonadism (gonadotropin or LHRH deficiency). Due to the risk of serious pulmonary oil microembolism (POME) and anaphylaxis, Aveed should only be used in patients where the clinical benefits outweigh these specific risks. **Limitations of Use:** Safety and efficacy have not been established in men with "age-related hypogonadism" or in males less than 18 years of age.
How AVEED Works
Aveed delivers testosterone undecanoate, which provides a source of exogenous testosterone. Endogenous androgens, including testosterone and its metabolite dihydrotestosterone (DHT), are responsible for the normal growth and development of male sex organs and the maintenance of secondary sex characteristics. These effects include the maturation of the prostate and seminal vesicles, the development of male hair distribution, laryngeal enlargement, and alterations in body musculature and fat distribution.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-03-05
- Patent Cliff
- 2027
- Routes
- INTRAMUSCULAR
- Dosage Forms
- INJECTABLE
AVEED Approval History
What AVEED Treats
1 indicationsAVEED is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypogonadism
AVEED Boxed Warning
SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose [s...
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose [see Warnings and Precautions ( 5.1 )] . Following each injection of AVEED, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis [see Warnings and Precautions ( 5.1 )] . Because of the risks of serious POME reactions and anaphylaxis, AVEED is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program [see Warnings and Precautions ( 5.2 )] . WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS See full prescribing information for complete boxed warning Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose ( 5.1 ). Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis ( 5.1 ). Aveed is available only through a restricted program called the Aveed REMS Program ( 5.2 ).
AVEED Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AVEED
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03576001 results posted | 2018P001431 R01HD093724-01 | Ph 2 | completed | Multimodality Intervention for Function and Metabolism in SCI |
| NCT05964920 | TESTO-MEM | Ph 2, Ph 3 | completed | Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? |
| NCT05081193 | J2178 IRB00284702 | Ph 2 | completed | Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer |
| NCT03721497 | 2018-002365-19 | Ph 4 | active not recruiting | Testosterone in Bariatric Patients |
| NCT02514629 | CMCS240281 | Ph 3 | completed | Testosterone, Metformin, or Both, for Hypogonadism in Obese Males |
| NCT06489457 SEMAT | SEMA-TESTO Hypogonadism 0120-26/2020/13 | Ph 3 | completed | The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity |
| NCT03851627 Test2Func | T2F12017 2017-001611-37 | Ph 4 | recruiting | Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism |
| NCT04120363 OPS II results posted | PBRC 2019-017 W81XWH19C0162, W81XWH19D0010 | Ph 4 | completed | Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations |
| NCT03815331 | MHB024 | Ph 4 | completed | Xiaflex® Plus Testosterone Treatment Pilot Study Protocol |
| NCT00911586 results posted | CLAR-09009 | Ph 2 | completed | Pharmacokinetic Study to Determine Time to Steady-state |
| NCT04545450 DUTMUSCLE-20 | DUTMUSCLE-20 | Ph 3 | completed | Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen |
| NCT02966652 | DITEST-001 | Ph 1 | completed | Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism |
| NCT03973840 | CLAR-18019 | Ph 1 | completed | Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes |
| NCT03792321 SETH2 | SBCE-KG-2014-1 | Ph 4 | completed | Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2) |
| NCT01206270 ALCeP | 160/10 | Ph 2, Ph 3 | completed | Androgen for Leydig Cell Proliferation |
| NCT01813201 TIC | TIC-0911 2009-016498-13 | Ph 4 | completed | Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects |
| NCT03126656 | TECHF001 | Ph 4 | completed | Effects of Testosterone on Myocardial Repolarization |
| NCT01919294 TEREPINS | STH16037 2012-002564-27 | Ph 2 | completed | Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) |
| NCT01516554 | 38486 812.14 | Ph 2 | terminated | Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients |
| NCT01724658 | CU0115 | Ph 2 | completed | Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AVEED FDA Label Details
Indications & Usage
FDA Label (PDF)AVEED is indicated for the treatment of Hypogonadism.
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or imme...
Pro Intelligence Preview
Deep insights for AVEED
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
Trial Analysis
- • 20 total trials
- • Stage: Declining
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment