Drug Overview

Rezvilutamide (also known as SHR3680) is an advanced, high-potency “Smart Drug” designed to treat prostate cancer. It belongs to the category of Targeted Therapy because it specifically identifies and blocks the signals that allow cancer cells to grow. Unlike traditional chemotherapy, which can affect many different types of cells in the body, rezvilutamide focuses specifically on the “engines” that drive prostate cancer.

In the global medical market, rezvilutamide represents a “second-generation” breakthrough. It was engineered to be more powerful and stay in the body longer than older treatments. For patients and healthcare professionals, this medication offers a more refined way to manage aggressive disease, often providing hope when other hormonal treatments are no longer enough.

Generic Name: Rezvilutamide
US Brand Names: None (Currently an investigational drug in the US; marketed internationally as Jiangteng)
Drug Class: Second-generation Androgen Receptor (AR) Antagonist
Route of Administration: Oral (Tablet)
FDA Approval Status: Investigational (Currently in global clinical trials; approved in other international markets)

What Is It and How Does It Work? (Mechanism of Action)

To understand how rezvilutamide works, imagine a prostate cancer cell is like a high-performance car. To move and grow, this car needs “fuel” (hormones called androgens, like testosterone). The car also has a “gas tank cap” called the Androgen Receptor (AR). When the fuel plugs into the cap, the engine starts.

Rezvilutamide acts as a “locking gas cap” that is impossible to open. At the molecular level, it works through three main steps:

Competitive Inhibition: Rezvilutamide travels through the blood and binds to the Androgen Receptor on the surface of the cancer cell. It sticks to the receptor much more tightly than natural hormones do, effectively “blocking the lock.”
Nuclear Translocation Inhibition: Usually, once a hormone binds to the receptor, the whole complex moves into the “brain” of the cell (the nucleus) to give orders to grow. Rezvilutamide prevents this move from happening. The signal is trapped outside the nucleus.
DNA Binding Inhibition: If any receptors do manage to get into the nucleus, rezvilutamide prevents them from touching the cell’s DNA. This stops the cell from reading the instructions it needs to multiply and spread.
Tumor Shrinkage: Without these growth instructions, the cancer cell starves, stops dividing, and eventually undergoes a process of “programmed cell death.”

FDA-Approved Clinical Indications

While currently under investigation by the FDA for the US market, rezvilutamide is recognized internationally for its effectiveness in specific stages of cancer.

Oncological Uses

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Used for patients whose prostate cancer has spread to other parts of the body but still responds to hormone-lowering treatments.
High-Risk Non-Metastatic Castration-Resistant Prostate Cancer: Research is ongoing for its use in patients whose cancer is not yet visible on scans but is showing rising hormone markers despite treatment.

Non-Oncological Uses

There are currently no non-oncological uses for this medication.

Dosage and Administration Protocols

Rezvilutamide is taken as a pill once a day. It is important to take it at the same time every day to keep the medicine level steady in your blood.

Parameter	Standard International Protocol
Standard Dose	240 mg (typically three 80 mg tablets)
Frequency	Once daily
Administration	Oral; can be taken with or without food
Duration	Continued as long as the cancer is controlled and side effects are manageable

Dose Adjustments:

Hepatic (Liver) Insufficiency: No starting dose adjustment is typically needed for mild liver issues. However, it is not recommended for patients with severe liver disease.
Renal (Kidney) Insufficiency: No specific dose adjustment is required for mild to moderate kidney issues, as the drug is primarily processed by the liver.

Clinical Efficacy and Research Results

Current clinical data from major studies (such as the CHART trial) conducted between 2020 and 2025 show significant benefits for patients.

Survival Rates: In large trials, patients taking rezvilutamide along with standard hormone therapy saw a 42% reduction in the risk of death compared to those on older treatments.
Progression-Free Survival: Numerical data indicates that the “Radiographic Progression-Free Survival” (the time a patient lives without the cancer growing on a scan) was significantly extended, with many patients going over 24 months without disease growth.
PSA Response: A very high percentage of patients (nearly 90%) saw a major drop in their PSA levels (a blood marker for prostate cancer) within the first few months of treatment.

Safety Profile and Side Effects

Black Box Warning:

None. (However, there are warnings regarding the risk of Seizures and Ischemic Heart Disease).

Common Side Effects (>10%)

Fatigue: Feeling unusually tired or weak.
Hot Flashes: Sudden feelings of warmth, usually in the face and neck.
Hypertension: An increase in blood pressure.
Hyperglycemia: An increase in blood sugar levels.
Weight Gain: A common effect of hormone-based therapies.

Serious Adverse Events

Seizures: A rare but serious risk; the drug may affect the brain’s electrical activity.
Ischemic Heart Disease: Blockages or reduced blood flow to the heart muscle.
Hepatotoxicity: Liver injury (monitored via regular blood tests).

Management Strategies

Blood Pressure Checks: Patients should monitor their blood pressure at home.
Energy Management: Light exercise and scheduled rest can help with fatigue.
Seizure Safety: Patients with a history of seizures should discuss this with their doctor before starting treatment.

Research Areas

In the fields of Immunotherapy and Targeted Therapy, researchers are looking at “Combo-Strategies.” Current research (2025) is exploring how rezvilutamide can be used alongside Checkpoint Inhibitors to help the immune system “wake up” and attack prostate cancer cells more effectively. There is also interest in whether this drug can be combined with PARP Inhibitors for patients with specific genetic mutations (BRCA1/2), creating a “double-hit” against the cancer’s ability to repair itself.

Patient Management and Practical Recommendations

Pre-treatment Tests to be Performed

Liver Function Panel: To establish a healthy baseline for the liver.
PSA Blood Test: To track the “starting point” of the cancer.
Baseline EKG: To ensure the heart is healthy.
Blood Sugar Test.

Precautions During Treatment

Fall Prevention: Because the drug can cause fatigue and dizziness, take extra care when walking or using stairs.
Contraception: Even though this is for prostate cancer, the drug can harm a developing fetus. Patients with female partners of childbearing age must use effective birth control during treatment and for 3 months after the last dose.

“Do’s and Don’ts” List

Do take your pills at the same time every day.
Do keep a log of your blood pressure readings.
Don’t stop taking the medication without talking to your oncologist, even if you feel better.
Don’t assume that “natural” testosterone boosters are safe; they will work against this medication.

Legal Disclaimer

Standard medical information disclaimer: This guide is for informational purposes only and does not constitute medical advice. Rezvilutamide is a high-potency targeted therapy and should only be used under the supervision of a licensed oncologist. Always consult with your healthcare provider to discuss your specific diagnosis and treatment plan. This content reflects clinical data available as of early 2026.