Last reviewed 2026-05-21 · How we verify

testosterone pellet (100 mg)

University of Sao Paulo General Hospital · Phase 3 active Small molecule Under review Quality 0/100

testosterone pellet (100 mg) is a Androgen replacement therapy Small molecule drug developed by University of Sao Paulo General Hospital. It is currently in Phase 3 development for Hypogonadism (testosterone deficiency), Age-related testosterone decline. Also known as: testosterone subdermal implant.

Testosterone pellet delivers sustained testosterone replacement to restore physiological hormone levels in hypogonadal patients.

A 100 mg testosterone pellet is a long-acting subcutaneous implant that acts as an androgen receptor agonist, which is a type of small molecule that binds to the androgen receptor. It is used to treat conditions such as hypogonadism, testosterone deficiency, and estrogen deficiency, as indicated by ClinicalTrials.gov.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 pellet (100 mg)
Also known as	testosterone subdermal implant
Sponsor	University of Sao Paulo General Hospital
Drug class	Androgen replacement therapy
Target	Androgen receptor
Modality	Small molecule
Therapeutic area	Endocrinology
Phase	Phase 3

Mechanism of action

The subcutaneous pellet formulation provides continuous testosterone release over several months, bypassing first-pass hepatic metabolism and maintaining stable serum levels. This restores androgen-dependent physiological functions including muscle mass, bone density, sexual function, and mood regulation in testosterone-deficient individuals.

Approved indications

Hypogonadism (testosterone deficiency)
Age-related testosterone decline

Common side effects

Polycythemia
Acne
Injection site reaction
Mood changes
Prostate-related symptoms

Key clinical trials

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 pellet (100 mg) CI brief — competitive landscape report
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University of Sao Paulo General Hospital portfolio CI

Frequently asked questions about testosterone pellet (100 mg)

What is testosterone pellet (100 mg)?

testosterone pellet (100 mg) is a Androgen replacement therapy drug developed by University of Sao Paulo General Hospital, indicated for Hypogonadism (testosterone deficiency), Age-related testosterone decline.

How does testosterone pellet (100 mg) work?

Testosterone pellet delivers sustained testosterone replacement to restore physiological hormone levels in hypogonadal patients.

What is testosterone pellet (100 mg) used for?

testosterone pellet (100 mg) is indicated for Hypogonadism (testosterone deficiency), Age-related testosterone decline.

Who makes testosterone pellet (100 mg)?

testosterone pellet (100 mg) is developed by University of Sao Paulo General Hospital (see full University of Sao Paulo General Hospital pipeline at /company/university-of-sao-paulo-general-hospital).

Is testosterone pellet (100 mg) also known as anything else?

testosterone pellet (100 mg) is also known as testosterone subdermal implant.

What drug class is testosterone pellet (100 mg) in?

testosterone pellet (100 mg) belongs to the Androgen replacement therapy class. See all Androgen replacement therapy drugs at /class/androgen-replacement-therapy.

What development phase is testosterone pellet (100 mg) in?

testosterone pellet (100 mg) is in Phase 3.

What are the side effects of testosterone pellet (100 mg)?

Common side effects of testosterone pellet (100 mg) include Polycythemia, Acne, Injection site reaction, Mood changes, Prostate-related symptoms.

What does testosterone pellet (100 mg) target?

testosterone pellet (100 mg) targets Androgen receptor and is a Androgen replacement therapy.

Drug class: All Androgen replacement therapy drugs
Target: All drugs targeting Androgen receptor
Manufacturer: University of Sao Paulo General Hospital — full pipeline
Therapeutic area: All drugs in Endocrinology
Indication: Drugs for Hypogonadism (testosterone deficiency)
Indication: Drugs for Age-related testosterone decline
Also known as: testosterone subdermal implant

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing