Hormonal Therapy Agent

ANDROFERT - Clinica de Andrologia e Reproducao Humana · Phase 2 active Small molecule Quality 10/100

Hormonal Therapy Agent is a Hormonal Therapy Small molecule drug developed by ANDROFERT - Clinica de Andrologia e Reproducao Humana. It is currently in Phase 2 development. Also known as: recombinant human chorionic gonadotropin, recombinant FSH.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Hormonal Therapy Agent
Also known as	recombinant human chorionic gonadotropin, recombinant FSH
Sponsor	ANDROFERT - Clinica de Andrologia e Reproducao Humana
Drug class	Hormonal Therapy
Modality	Small molecule
Phase	Phase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

• Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers (PHASE1, PHASE2)
• Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (PHASE1, PHASE2)
• ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors (PHASE1, PHASE2)
• A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (PHASE3)
• SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
• Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery. (NA)
• Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (PHASE2)
• I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)

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:

• Hormonal Therapy Agent CI brief — competitive landscape report
• Hormonal Therapy Agent updates RSS · CI watch RSS
• ANDROFERT - Clinica de Andrologia e Reproducao Humana portfolio CI

Frequently asked questions about Hormonal Therapy Agent

What is Hormonal Therapy Agent?

Hormonal Therapy Agent is a Hormonal Therapy drug developed by ANDROFERT - Clinica de Andrologia e Reproducao Humana.

Who makes Hormonal Therapy Agent?

Hormonal Therapy Agent is developed by ANDROFERT - Clinica de Andrologia e Reproducao Humana (see full ANDROFERT - Clinica de Andrologia e Reproducao Humana pipeline at /company/androfert-clinica-de-andrologia-e-reproducao-humana).

Is Hormonal Therapy Agent also known as anything else?

Hormonal Therapy Agent is also known as recombinant human chorionic gonadotropin, recombinant FSH.

What drug class is Hormonal Therapy Agent in?

Hormonal Therapy Agent belongs to the Hormonal Therapy class. See all Hormonal Therapy drugs at /class/hormonal-therapy.

What development phase is Hormonal Therapy Agent in?

Hormonal Therapy Agent is in Phase 2.

Related

• Drug class: All Hormonal Therapy drugs
• Manufacturer: ANDROFERT - Clinica de Andrologia e Reproducao Humana — full pipeline
• Also known as: recombinant human chorionic gonadotropin, recombinant FSH