What is ONC201?

ONC201 is an oral, small-molecule drug that selectively targets and destroys aggressive cancer cells while leaving healthy cells unharmed. Currently in clinical trials, it has shown remarkable promise for recurrent glioblastoma (GBM), diffuse intrinsic pontine glioma (DIPG), and other H3 K27M-mutant cancers, diseases with few effective treatments and devastating survival rates.

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Who is Eligible for ONC201 Treatment?

Clinical trials are crucial to determine the effectiveness of a clinical strategy, drug, treatment, or tool. Eligibility for ONC201 clinical trials typically includes adults (18 years or older) with specific types of glioma who have completed standard frontline radiotherapy within a defined period (usually 2–6 weeks before randomization).

Patients should not have primary spinal tumors and must not be pregnant or breastfeeding during treatment or for a set period after the last dose.

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How Does ONC201 Work?

Targets DRD2: Blocks the dopamine receptor D2 (DRD2), a protein overexpressed in brain cancers that fuels tumor growth.
Triggers Apoptosis: Forces cancer cells into self-destruction (TRAIL pathway activation) without harming normal cells.
Overcomes Resistance: Works even in treatment-resistant tumors, offering hope where other therapies fail.

Cost of ONC201 Treatment

Bringing a new cancer drug to market in the U.S. is a costly process. Here’s a rough estimate of the financial needs for ONC201:

1. Clinical Trial for ONC201 Costs

Phase I Trials: $5–$15 million (safety & dosage testing)

Phase II Trials: $10–$20 million (efficacy in specific cancers)

Phase III Trials: $20–$50 million (large-scale testing for FDA approval)

2. FDA Approval & Manufacturing

Regulatory Fees: ~$3 million (PDUFA, advisory committee reviews)

GMP Manufacturing: $5–$10 million (scaling up production)

3. Post-Approval & Accessibility

Insurance & Reimbursement For ONC201 Costs: Advocacy is needed to ensure coverage by Medicare/Medicaid and private insurers.

Patient Assistance Programs: Funding helps subsidize costs for uninsured or underinsured patients.

Total Estimated ONC201 Costs to Market: $50–$100 million (varies based on trial complexity and duration).

WhyDonate Fundraising Stories

Help Amira (DIPG=brain stem tumor) with her medical treatment

Children should be able to play outside, go to school, and enjoy their early years without any worries.
Unfortunately, these beautiful dream images are currently not the reality for our dear Amira. Amira is only five years old and she was recently diagnosed with a brain stem tumor. In medical jargon, this is also called DIPG (Diffuse Intrinsic Pontine Glioma).

DIPG is a rare form of tumor for which no specific treatment is offered in the Netherlands, apart from radiation and chemotherapy

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Semmy Foundation

The Semmy Foundation aims to increase the life expectancy and ultimately the chances of survival of children with brainstem cancer. Together with all our donors, we are committed to the fight against this disease. Will you help?

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‘Stop brain tumor growth and help Wesley live longer!’

I am Wesley, 31 years old. Married to Martine and last October our first son ‘Milan’ was born.
Stand in life as a bon vivant but also as a fanatic football enthusiast. Since April 2021 I have heard that I am terminally ill, diagnosed with a brain tumor: Diffuse Midline Glioma, WHO grade 4, with a rare H3K27M mutation. Donations are required for ONC201 treatment in France!

I very much hope that with this fundraiser we can raise money to start treatment in France. The money raised is handled carefully and is supervised by several parties. I am very grateful to you for every euro that is donated so that I can continue my treatment and hopefully make many more memories with you!

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What is ONC201?

Who is Eligible for ONC201 Treatment?

How Does ONC201 Work?