Last reviewed · How we verify

Testosterone Gel Wolff

University Hospital Muenster · Phase 3 active Small molecule Under review Quality 0/100

Testosterone Gel Wolff is a androgen Small molecule drug developed by University Hospital Muenster. It is currently in Phase 3 development for Treatment of hypogonadism in men.

Testosterone gel increases testosterone levels in the body.

Testosterone Gel Wolff is a testosterone gel used to treat hypogonadism, a condition where the body does not produce enough testosterone. It works by acting as an androgen receptor agonist, binding to the androgen receptor to mimic the effects of natural testosterone.

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 nameTestosterone Gel Wolff
SponsorUniversity Hospital Muenster
Drug classandrogen
Targetandrogen receptor
ModalitySmall molecule
Therapeutic areaUrology
PhasePhase 3

Mechanism of action

Testosterone is an androgen hormone that plays a key role in the development and maintenance of male reproductive tissues and secondary sexual characteristics. By increasing testosterone levels, testosterone gel can help alleviate symptoms of hypogonadism, such as low libido, fatigue, and decreased muscle mass.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Testosterone Gel Wolff

What is Testosterone Gel Wolff?

Testosterone Gel Wolff is a androgen drug developed by University Hospital Muenster, indicated for Treatment of hypogonadism in men.

How does Testosterone Gel Wolff work?

Testosterone gel increases testosterone levels in the body.

What is Testosterone Gel Wolff used for?

Testosterone Gel Wolff is indicated for Treatment of hypogonadism in men.

Who makes Testosterone Gel Wolff?

Testosterone Gel Wolff is developed by University Hospital Muenster (see full University Hospital Muenster pipeline at /company/university-hospital-muenster).

What drug class is Testosterone Gel Wolff in?

Testosterone Gel Wolff belongs to the androgen class. See all androgen drugs at /class/androgen.

What development phase is Testosterone Gel Wolff in?

Testosterone Gel Wolff is in Phase 3.

What are the side effects of Testosterone Gel Wolff?

Common side effects of Testosterone Gel Wolff include Skin irritation.

What does Testosterone Gel Wolff target?

Testosterone Gel Wolff targets androgen receptor and is a androgen.

Related

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