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Hernexeos

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Hernexeos

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Hernexeos
Generic Name (API): Zongertinib
Dosage Form & Strength: 60 Mg
Route: Oral
Drug Class: HER2 tyrosine kinase inhibitor

Manufacturer / Innovator:

Singapore

Regulatory Approval:

  • FDA-approved (accelerated approval
  • August 2025; expanded to treatment-naive patients
  • February 2026) for adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain activating mutations
  • as
Family enjoying life with Named Patient Program access

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  • 100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.

    100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.

  • Medicines sourced from authorized manufacturers with full batch traceability

    Medicines sourced from authorized manufacturers with full batch traceability.

  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

    EU-GDP compliant warehousing for secure, quality-controlled global distribution.

  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

GDP Compliant
Licensed Wholesale distributor

Understanding Hernexeos (Zongertinib) and Its Medical Uses

Hernexeos (zongertinib) is the first oral targeted therapy for HER2-mutant advanced non-small cell lung cancer, offering an oral alternative to infused HER2-targeted therapies for this patient population.

Approved Indication

Hernexeos is FDA-approved for adults with unresectable or metastatic nonsquamous NSCLC harboring HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test — both as an initial treatment option and for previously treated patients.

How It Works

Zongertinib selectively blocks phosphorylation of HER2, reducing downstream signaling that drives proliferation in lung cancer cells with activating HER2 tyrosine kinase domain mutations.

Dosing

The dose is weight-based: 120 mg orally once daily for patients under 90 kg (198 lb), or 180 mg orally once daily for patients 90 kg or more, taken with or without food, continued until disease progression or unacceptable toxicity, as determined by the treating oncologist.

Warnings and Precautions for Hernexeos

Hernexeos requires monitoring for several important safety considerations.

Interstitial Lung Disease / Pneumonitis

Severe and life-threatening ILD/pneumonitis can occur, with a median onset around 13 weeks after starting treatment. Monitor for new or worsening dyspnea, cough, or fever, and interrupt, reduce, or discontinue treatment based on severity.

Diarrhea

Among the most common adverse reactions. Patients should contact their treating physician promptly if diarrhea occurs.

Left Ventricular Dysfunction

Monitor left ventricular ejection fraction at baseline and at regular intervals during treatment, with dose adjustment as needed.

Embryo-Fetal Toxicity

Hernexeos can cause fetal harm. Effective contraception is required during treatment and for a defined period after the final dose.

  • Report any new or worsening breathing symptoms to the treating physician immediately.
  • Cardiac function monitoring is required at baseline and during treatment.
  • Contact your care team promptly if diarrhea develops.

How to Access Hernexeos in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Hernexeos

Hernexeos (zongertinib) received FDA accelerated approval in August 2025, expanded to treatment-naive patients in February 2026, and is manufactured by Boehringer Ingelheim as the first oral targeted therapy for HER2-mutant NSCLC.

Documentation Required

Import of Hernexeos through a Named Patient Program requires a valid prescription from the treating oncologist, confirmation of HER2 tyrosine kinase domain mutation status via an FDA-approved test, and supporting clinical documentation as required by Indian regulatory authorities.

Sourcing

NPP sources Hernexeos directly from Boehringer Ingelheim's authorized supply chain to ensure product authenticity and regulatory compliance.

Sourcing and Delivery of Hernexeos

Hernexeos is sourced through verified, GDP-compliant channels from Boehringer Ingelheim's authorized supply chain to ensure authenticity and quality.

Storage Requirements

Hernexeos tablets should be stored at 20°C to 25°C (68°F to 77°F), in the original bottle with the desiccants inside, and used within 3 months of first opening.

Delivery Process

Once sourced, Hernexeos is packed and transported under appropriate temperature-controlled conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.

Availability of Hernexeos Across Major Cities in India

Patients across India can access Hernexeos through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.

Mumbai

Leading oncology centers in Mumbai support HER2 mutation testing and treatment coordination for Hernexeos access.

Delhi

Delhi's major cancer hospitals assist patients with molecular testing and prescription support for Hernexeos.

Bangalore

Bangalore's oncology network offers access to HER2 testing and treatment planning for eligible NSCLC patients.

Chennai

Chennai-based specialists coordinate Hernexeos access alongside comprehensive lung cancer care.

Hyderabad

Hyderabad's cancer care institutions support patients pursuing Hernexeos therapy following confirmed HER2 mutation status.

Kolkata

Kolkata's oncology centers help coordinate documentation and treatment access for Hernexeos.

Pune

Pune-based oncologists assist with HER2 mutation testing and Hernexeos treatment planning.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Hernexeos.

Kochi

Kochi's oncology units assist patients with the documentation needed for Hernexeos access.

Chandigarh

Chandigarh's cancer care centers support Hernexeos treatment coordination for patients from North India.

Jaipur

Jaipur's oncology specialists help patients navigate the Hernexeos access process.

Lucknow

Lucknow-based cancer centers assist patients pursuing Hernexeos therapy.

Bhubaneswar

Bhubaneswar's oncology institutions support access to Hernexeos for eligible patients.

Guwahati

Guwahati's specialists help coordinate Hernexeos access for patients across the Northeast.

Patients in other cities across India can also access Hernexeos through NPP's nationwide coordination network.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 10 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 10 September 2026

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