Long-term course of antiandrogen drugs

The First Affiliated Hospital with Nanjing Medical University · Phase 3 active Small molecule

Long-term course of antiandrogen drugs is a Antiandrogen Small molecule drug developed by The First Affiliated Hospital with Nanjing Medical University. It is currently in Phase 3 development for Prostate cancer (hormone-sensitive), Androgen-dependent conditions requiring long-term hormonal suppression. Also known as: Rezvilutamide.

Antiandrogen drugs block the effects of androgens (male hormones) by inhibiting androgen receptor signaling.

Antiandrogen drugs block the effects of androgens (male hormones) by inhibiting androgen receptor signaling. Used for Prostate cancer (hormone-sensitive), Androgen-dependent conditions requiring long-term hormonal suppression.

Likelihood of approval

61.3% 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).
• Oncology Phase 3 boost +3.0pp
  Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

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	Long-term course of antiandrogen drugs
Also known as	Rezvilutamide
Sponsor	The First Affiliated Hospital with Nanjing Medical University
Drug class	Antiandrogen
Target	Androgen receptor
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Antiandrogens work by competitively binding to androgen receptors or inhibiting androgen synthesis, thereby reducing the biological activity of testosterone and other androgens. This mechanism is used to suppress androgen-dependent cell growth and proliferation. Long-term courses are typically employed in hormone-sensitive conditions where sustained androgen suppression is therapeutically beneficial.

Approved indications

• Prostate cancer (hormone-sensitive)
• Androgen-dependent conditions requiring long-term hormonal suppression

Common side effects

• Hot flashes
• Erectile dysfunction
• Gynecomastia
• Fatigue
• Decreased libido

Key clinical trials

• Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC (PHASE3)

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:

• Long-term course of antiandrogen drugs CI brief — competitive landscape report
• Long-term course of antiandrogen drugs updates RSS · CI watch RSS
• The First Affiliated Hospital with Nanjing Medical University portfolio CI

Frequently asked questions about Long-term course of antiandrogen drugs

What is Long-term course of antiandrogen drugs?

Long-term course of antiandrogen drugs is a Antiandrogen drug developed by The First Affiliated Hospital with Nanjing Medical University, indicated for Prostate cancer (hormone-sensitive), Androgen-dependent conditions requiring long-term hormonal suppression.

How does Long-term course of antiandrogen drugs work?

Antiandrogen drugs block the effects of androgens (male hormones) by inhibiting androgen receptor signaling.

What is Long-term course of antiandrogen drugs used for?

Long-term course of antiandrogen drugs is indicated for Prostate cancer (hormone-sensitive), Androgen-dependent conditions requiring long-term hormonal suppression.

Who makes Long-term course of antiandrogen drugs?

Long-term course of antiandrogen drugs is developed by The First Affiliated Hospital with Nanjing Medical University (see full The First Affiliated Hospital with Nanjing Medical University pipeline at /company/the-first-affiliated-hospital-with-nanjing-medical-university).

Is Long-term course of antiandrogen drugs also known as anything else?

Long-term course of antiandrogen drugs is also known as Rezvilutamide.

What drug class is Long-term course of antiandrogen drugs in?

Long-term course of antiandrogen drugs belongs to the Antiandrogen class. See all Antiandrogen drugs at /class/antiandrogen.

What development phase is Long-term course of antiandrogen drugs in?

Long-term course of antiandrogen drugs is in Phase 3.

What are the side effects of Long-term course of antiandrogen drugs?

Common side effects of Long-term course of antiandrogen drugs include Hot flashes, Erectile dysfunction, Gynecomastia, Fatigue, Decreased libido.

What does Long-term course of antiandrogen drugs target?

Long-term course of antiandrogen drugs targets Androgen receptor and is a Antiandrogen.

Related

• Drug class: All Antiandrogen drugs
• Target: All drugs targeting Androgen receptor
• Manufacturer: The First Affiliated Hospital with Nanjing Medical University — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Prostate cancer (hormone-sensitive)
• Indication: Drugs for Androgen-dependent conditions requiring long-term hormonal suppression
• Also known as: Rezvilutamide