Trutakna (Atacicept-vymj)

Trutakna (atacicept-vymj) is a B-lymphocyte stimulator (BLyS/BAFF)-specific inhibitor and A Proliferation-Inducing Ligand (APRIL) blocker indicated to reduce proteinuria in adults with primary Immunoglobulin A Nephropathy (IgAN) who are at risk for disease progression.

This indication has received accelerated approval based on a reduction in proteinuria. It has not yet been established whether Trutakna slows long-term kidney function decline in patients with IgA nephropathy. Continued FDA approval may depend on confirmation of clinical benefit in ongoing confirmatory clinical trials.

IgA nephropathy (IgAN), also known as Berger’s disease, is a chronic autoimmune kidney disorder characterized by the deposition of abnormal Immunoglobulin A (IgA) antibodies in the kidneys. These immune deposits trigger inflammation within the glomeruli, leading to persistent proteinuria, progressive kidney damage, declining kidney function, and, in some patients, kidney failure requiring dialysis or transplantation.

Trutakna works by simultaneously blocking BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand)—two key immune signaling proteins involved in the production and survival of antibody-producing B cells and plasma cells. By inhibiting both pathways, atacicept reduces the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), helping decrease immune complex formation and kidney inflammation. This targeted mechanism helps reduce urinary protein loss, an important marker associated with progression of IgA nephropathy.

Trutakna is a prescription biological medicine and should only be used under the supervision of a qualified nephrologist or healthcare professional experienced in managing patients with IgA nephropathy.

Recommended Dosage:
The recommended dosage of Trutakna is 150 mg administered by subcutaneous (SC) injection once weekly. Trutakna is supplied as a single-dose prefilled autoinjector designed for self-administration after appropriate training by a healthcare professional. Patients should continue treatment as prescribed by their physician while receiving standard supportive therapy for IgA nephropathy.

If a dose is missed, administer the missed dose as soon as possible. Thereafter, resume the once-weekly dosing schedule, with the next injection administered one week after the missed dose is given.
Patients should not administer two doses to make up for a missed dose and should always follow the instructions provided by their treating physician.

• Trutakna suppresses specific components of the immune system and may increase the risk of serious bacterial, viral, fungal, or opportunistic infections. Patients should immediately inform their physician if they develop fever, chills, persistent cough, painful urination, or other signs of infection. Treatment may need to be delayed or interrupted until the infection has resolved.
• Live or live-attenuated vaccines should generally be avoided during treatment with Trutakna and for an appropriate period before initiating therapy. Patients should discuss their vaccination history with their healthcare provider prior to starting treatment.
• Serious hypersensitivity reactions, including allergic reactions, may occur. Patients experiencing swelling of the face or throat, difficulty breathing, severe rash, or other symptoms of an allergic reaction should seek immediate medical attention. Trutakna is contraindicated in patients with a known serious hypersensitivity to atacicept-vymj or any component of the formulation.
• Patients may require periodic laboratory monitoring during treatment, including kidney function assessment, urine protein measurements, and blood investigations as recommended by their treating physician. Monitoring helps evaluate treatment response and detect any adverse effects requiring dose interruption or discontinuation.
• There are limited data regarding the use of Trutakna during pregnancy or breastfeeding. Women who are pregnant, planning pregnancy, or breastfeeding should discuss the potential risks and benefits with their treating physician before starting treatment. Women of childbearing potential should consult their physician regarding appropriate contraceptive measures during therapy.
• Before starting Trutakna, patients should inform their healthcare provider about all prescription medicines, over-the-counter medicines, vitamins, herbal supplements, and biological therapies they are currently taking. Certain immunosuppressive medicines or biologics may increase the risk of infections when used together with Trutakna.

Global Approval Status:

Trutakna (atacicept-vymj) has received regulatory approval for the treatment of adults with primary Immunoglobulin A Nephropathy (IgAN) who are at risk for disease progression.

• United States: The U.S. Food and Drug Administration (FDA) granted Accelerated Approval to Trutakna (atacicept-vymj) on July 7, 2026 for reducing proteinuria in adults with primary IgA nephropathy at risk for disease progression. The approval was based on a clinically meaningful reduction in proteinuria observed in the pivotal Phase 3 ORIGIN 3 trial. Continued FDA approval may be contingent upon verification of long-term clinical benefit in the ongoing confirmatory study.
  Trutakna is the first FDA-approved therapy that simultaneously inhibits BAFF (BLyS) and APRIL, two important immune mediators involved in the pathogenesis of IgA nephropathy.
• Other Countries: As of the current publicly available information, Trutakna has not yet received marketing approval in India. Approval status in Europe, the United Kingdom, Australia, Canada, Japan, and other countries may vary as regulatory reviews continue. Patients should consult local regulatory authorities or healthcare providers regarding country-specific availability

Approval was supported by the pivotal ORIGIN 3 study (ClinicalTrials.gov NCT04716231), a randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating atacicept-vymj in adults with biopsy-confirmed primary Immunoglobulin A Nephropathy (IgAN) who remained at risk for disease progression despite optimized supportive care. Patients received Trutakna (atacicept-vymj) 150 mg by subcutaneous injection once weekly in addition to standard supportive therapy. At the prespecified interim analysis at 36 weeks, patients treated with Trutakna achieved an approximately 46% reduction from baseline in proteinuria, representing an approximately 42% greater reduction compared with placebo (p<0.0001). The most commonly reported adverse reactions included upper respiratory tract infections, nasopharyngitis, influenza, bronchitis, urinary tract infections, injection-site reactions, and headache, while the overall safety profile was considered acceptable and generally consistent with its mechanism of action.

Atacicept-vymj was discovered and developed by Vera Therapeutics, Inc. The U.S. Food and Drug Administration (FDA) granted Accelerated Approval to Trutakna in July 2026 for reducing proteinuria in adults with primary IgA nephropathy at risk for disease progression. Continued approval for this indication may be contingent upon verification and confirmation of long-term clinical benefit in the ongoing ORIGIN 3 confirmatory study.

Note: Approval and marketing status vary by country. As of the current publicly available information, Trutakna is not approved or commercially marketed in India.

What documents are required to import Trutakna to India?

Trutakna (atacicept-vymj) may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a qualified doctor
• The patient’s diagnostic reports
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and an import permit, if applicable.

Is Trutakna available in India?

Trutakna (atacicept-vymj injections) is a prescription medicine that legally requires a doctor’s prescription to be dispensed. As of the current publicly available information, Trutakna is not commercially marketed in India.

However, patients in India can legally access Trutakna through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

Indian Pharma Network (IPN) acts as a facilitator under named patient supply, providing input on:

• Availability of Trutakna in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune, etc.) and pathways to access it
• Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE).
  Trutakna price in India under the NPP route
• Sourcing from genuine, reliable channels in the USA, Canada, Europe, and Australia
• Ensuring full transparency throughout the process

Trutakna can be made available to patients, doctors, and hospitals in Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others— and can facilitate delivery to the patient’s treating hospital. Orders are confirmed only after receipt of a valid doctor’s prescription and an import permit, where applicable.  

Indian Pharma Network (IPN) can source Trutakna from reliable channels across the world and facilitate supply to patients, doctors, and hospitals, offering worldwide access to this treatment under applicable legal provisions. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the patient’s address from New Delhi, India, after legal requirements are fulfilled.

For Trutakna cost in India and availability, contact IPN at WhatsApp: +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@indianpharmanetwork.in.

What is the generic name for the brand drug Trutakna?

Atacicept-vymj is the generic name for the brand drug Trutakna.

What is Trutakna used for?

Trutakna (atacicept-vymj) is indicated to reduce proteinuria in adults with primary Immunoglobulin A Nephropathy (IgAN) who are at risk for disease progression. The FDA granted accelerated approval based on reduction in proteinuria. Continued approval may depend on confirmation of long-term clinical benefit in ongoing studies.

Who develops and manufactures Trutakna?

Trutakna was developed and is manufactured by Vera Therapeutics, Inc., a biotechnology company focused on developing therapies for serious immunological kidney diseases.

What type of medicine is Trutakna?

Trutakna is a biological medicine that acts as a dual BAFF (BLyS) and APRIL inhibitor. By blocking these immune signaling proteins, it helps reduce the production of harmful antibodies involved in IgA nephropathy.

Is Trutakna approved by the FDA?

Yes. Trutakna (atacicept-vymj) received Accelerated Approval from the U.S. Food and Drug Administration (FDA) on July 7, 2026 for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression.

Where is Trutakna approved?

As of current publicly available information, Trutakna has been approved in the United States by the FDA. Regulatory submissions or reviews in other countries may still be ongoing.

What strength and dosage form is available?

Trutakna is supplied as a 150 mg/mL single-dose prefilled autoinjector for subcutaneous injection.

What are the most common side effects of Trutakna?

The most commonly reported side effects are upper respiratory tract infection, injection site reaction and injection site erythema.

How does Trutakna import in India work?

Trutakna import in India is possible through the Named Patient Program (NPP) — on behalf of an individual patient with a valid doctor’s prescription. Indian Pharma Network (IPN) helps manage the process, including documentation, approvals, and delivery, so the medicine reaches the patient safely and legally.

Who is a reliable Trutakna supplier in India?

Indian Pharma Network (IPN) facilitates compliant access to Trutakna in India through global sourcing channels and structured documentation support for eligible patients, in accordance with applicable regulatory provisions.

How much does Trutakna cost in India?

Trutakna is not yet approved or marketed in India, but patients can legally access it through the Named Patient Program. Prices may vary over time due to market and regulatory factors. For the latest Trutakna cost in India, call +91 96548 60915 or WhatsApp +91 98104 69557 or email info@indianpharmanetwork.in.

Can Trutakna be accessed in SAARC countries?

Yes. In addition to Gulf countries, Trutakna can be accessed through import provisions such as the Named Patient Program in SAARC countries (India, Afghanistan, Maldives, Nepal, Bangladesh, Bhutan, Pakistan, and Sri Lanka). IPN can help facilitate compliant supply where permitted by local regulations.

Is it safe to buy Trutakna Injections online in India?

Yes, one can buy Trutakna in India through the Indian Pharma Network (IPN), as this product is not yet registered or available in the country. IPN can help facilitate the import of Trutakna Injections through legal channels.

Can Trutakna be delivered to my treating hospital?

Yes. IPN can facilitate delivery of Trutakna to the patient’s treating hospital across major Indian cities, under the Named Patient Program, with a valid doctor’s prescription and import permit where applicable. Leading hospitals include AIIMS Delhi, Sir Ganga Ram Hospital, Medanta – The Medicity, Apollo Hospitals Chennai, Christian Medical College (CMC), PGIMER, Kidwai Memorial Institute of Oncology, Adyar Cancer Institute, Amrita Hospital, Artemis Hospital, Safdarjung Hospital, Kauvery Hospital, Sri Ramachandra Medical Centre, Cytecare Cancer Hospital, MIOT International, SCTIMST, NIMS Hospital, KIMS Hospitals, AIG Hospitals, Bombay Hospital, Lilavati Hospital, Care Hospitals, Narayana Health City, Jaslok Hospital, Yashoda Hospitals, Fortis Memorial Research Institute, Kokilaben Dhirubhai Ambani Hospital, P. D. Hinduja Hospital, Manipal Hospitals, Aster Medcity, Indraprastha Apollo Hospital, King George’s Medical University (KGMU), Shalby Hospitals, Tata Memorial Centre, HCG Cancer Center, Basavatarakam Indo-American Cancer Hospital, Cancer Institute (WIA), Max Healthcare, and Rajiv Gandhi Cancer Institute & Research Centre.

What are the storage conditions for Trutakna Injections?

Trutakna should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in its original carton to protect it from light. Do not freeze or shake the autoinjector. If necessary, Trutakna may be kept at room temperature for a limited period as specified in the official prescribing information.

Disclaimer: Trutakna (atacicept-vymj) is a prescription biological medicine and should only be used under the supervision of a qualified healthcare professional. Product availability, regulatory approvals, and import requirements vary by country. This medicine is intended for adults with primary Immunoglobulin A Nephropathy (IgAN) who meet the approved indication and eligibility criteria. Information provided on this page is intended for educational purposes only and should not be considered medical advice, a substitute for professional healthcare consultation, or a recommendation to self-medicate. Patients should always consult their treating physician regarding diagnosis, treatment options, and eligibility for access through the Named Patient Program.