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testosterone undecanoate alone
testosterone undecanoate alone is a Androgen replacement therapy Small molecule drug developed by Unita Complessa di Ostetricia e Ginecologia. It is currently in Phase 3 development for Testosterone deficiency (hypogonadism), Male infertility (potential indication in phase 3). Also known as: Nebid.
Testosterone undecanoate is an androgen that binds to androgen receptors to replace or supplement testosterone in the body.
Testosterone undecanoate is an androgen that binds to androgen receptors to replace or supplement testosterone in the body. Used for Testosterone deficiency (hypogonadism), Male infertility (potential indication in phase 3).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | testosterone undecanoate alone |
|---|---|
| Also known as | Nebid |
| Sponsor | Unita Complessa di Ostetricia e Ginecologia |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Testosterone undecanoate is a long-acting ester of testosterone that, when administered, is hydrolyzed to release free testosterone. It binds to androgen receptors throughout the body to restore physiological testosterone levels and promote androgenic and anabolic effects. This mechanism is used to treat testosterone deficiency states and potentially other conditions where androgen supplementation is therapeutically beneficial.
Approved indications
- Testosterone deficiency (hypogonadism)
- Male infertility (potential indication in phase 3)
Common side effects
- Polycythemia
- Acne
- Injection site reactions
- Mood changes
- Prostate-related effects
Key clinical trials
- Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway
- Testosterone-induced Muscle Memory and Underlying Mechanisms (NA)
- Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders (NA)
- Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration (EARLY_PHASE1)
- Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 (PHASE1, PHASE2)
- Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations (PHASE4)
- Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation (PHASE2)
- Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism (PHASE1)
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 |
|---|---|
| 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:
- testosterone undecanoate alone CI brief — competitive landscape report
- testosterone undecanoate alone updates RSS · CI watch RSS
- Unita Complessa di Ostetricia e Ginecologia portfolio CI
Frequently asked questions about testosterone undecanoate alone
What is testosterone undecanoate alone?
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Is testosterone undecanoate alone also known as anything else?
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Related
- Drug class: All Androgen replacement therapy drugs
- Target: All drugs targeting Androgen receptor
- Manufacturer: Unita Complessa di Ostetricia e Ginecologia — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Testosterone deficiency (hypogonadism)
- Indication: Drugs for Male infertility (potential indication in phase 3)
- Also known as: Nebid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing