Modeyso (dordaviprone) is the first and only FDA-approved treatment (August 2025) for H3 K27M-mutant diffuse midline glioma, a rare and aggressive brain cancer. This protease activator works by inducing cancer cell death while slowing tumor growth.
Key Facts About Modeyso
| Aspect | Details |
|---|---|
| Generic Name | Dordaviprone |
| Brand Name | Modeyso |
| FDA Approval Date | August 6, 2025 |
| Approval Type | Accelerated (based on ONC006-ONC018 trials) |
| Dosage Form | Capsule (125mg) |
| Mechanism of Action | Activates ClpP enzyme, inhibits dopamine D2 receptor |
| Who Can Take It? | Adults & children (1+ years) with progressing disease |
Table of Contents
What is Modeyso Used For?
Modeyso (dordaviprone) is specifically approved for:
- Diffuse midline glioma with H3 K27M mutation (a rare, aggressive brain tumor)
- Patients 1 year and older whose cancer has progressed after prior treatment
🔬 Off-label potential: Researchers are studying its effects on other ClpP-sensitive cancers (e.g., certain leukemias, sarcomas).
Modeyso Dosage & Administration
How to Take Modeyso
✔ Once weekly (same day each week)
✔ Empty stomach (1 hour before or 3 hours after food)
✔ Swallow whole or mix with 15-30mL liquid (if unable to swallow)
Dosage Guidelines
| Patient Group | Recommended Dose |
|---|---|
| Adults | 625mg once weekly |
| Children (1-17 yrs, ≥10kg) | Based on weight: |
| – 10kg to <12.5kg | 125mg weekly |
| – 12.5kg to <27.5kg | 250mg weekly |
| – 27.5kg to <42.5kg | 375mg weekly |
| – 42.5kg to <52.5kg | 500mg weekly |
| – ≥52.5kg | 625mg weekly |
How Does Modeyso Work?
Modeyso has a dual mechanism:
- Activates ClpP enzyme → Triggers cancer cell self-destruction
- Blocks dopamine D2 receptors → Slows tumor growth
Clinical Impact: In trials, this combination led to:
- Tumor shrinkage in 22% of patients
- 73% of responders saw benefits last ≥6 months
Modeyso Side Effects & Warnings
Common Side Effects
- Fatigue
- Headache
- Nausea/vomiting
- Muscle/joint pain
- Low blood cell counts
Serious Risks
Allergic Reactions (rash, swelling, trouble breathing)
Heart Rhythm Problems (QT prolongation → torsades de pointes)
Fertility Issues (may affect ability to have children)
Monitoring Required
✔ ECG (before & during treatment)
✔ Blood tests (electrolytes, liver function)
✔ Pregnancy test (before starting)
Modeyso Cost & Insurance Coverage
| Cost Factor | Details |
|---|---|
| Estimated Price | $15,000-$20,000/month |
| Insurance Coverage | Prior authorization typically required |
| Patient Assistance | Jazz Pharmaceuticals may offer programs |
| Generic Availability | Not expected before 2035 |
Modeyso vs. Other Glioma Treatments
| Treatment | Response Rate | Administration | Key Advantage |
|---|---|---|---|
| Modeyso | 22% | Oral (weekly) | Targets H3 K27M mutation |
| Radiation | 40-60% | Clinic visits | Local control |
| Chemo (TMZ) | 10-15% | Daily pills | Wide availability |
| ONC201 | 15% (in trials) | Oral | Similar mechanism |
How Much Does H3 K27M Treatment Cost?
1. Modeyso (Dordaviprone)
| Cost Factor | Details |
|---|---|
| Estimated Price | $15,000–$20,000 per month |
| Dosing Frequency | Once weekly (oral capsule) |
| Insurance Coverage | Prior authorization required (varies by plan) |
| Patient Assistance | Jazz Pharmaceuticals may offer co-pay programs |
| Generic Availability | Not expected before 2035+ |
Total Annual Cost: ~$180,000–$240,000
2. Radiation Therapy (Standard Treatment)
| Cost Factor | Details |
|---|---|
| Estimated Price | $10,000–$50,000 (full course) |
| Duration | Typically 6 weeks (5 days/week) |
| Insurance Coverage | Usually covered (may require co-pay) |
Often used before/with Modeyso
3. Chemotherapy (Temozolomide/TMZ)
| Cost Factor | Details |
|---|---|
| Estimated Price | $500–$5,000 per cycle |
| Dosing Frequency | Daily or 5 days/month |
| Insurance Coverage | Generally covered (generic available) |
Less effective for H3 K27M, but lower cost
4. Clinical Trials (Potential Low-Cost Option)
| Cost Factor | Details |
|---|---|
| Estimated Price | Often free (sponsored by drug companies) |
| Availability | Limited slots, strict eligibility |
| Best For | Patients who exhaust standard treatments |
Search trials at ClinicalTrials.gov
How to Afford H3 K27M Treatment?
✅ 5 Ways to Reduce Costs
- Insurance Appeals
- Work with your doctor to justify medical necessity.
- Some plans cover 80-90% after prior authorization.
- Patient Assistance Programs
- JazzCares (for Modeyso)Â may offer co-pay help.
- Nonprofits like PAN Foundation aid with out-of-pocket costs.
- Hospital Payment Plans
- Many centers offer interest-free installment plans.
- Off-Label Alternatives
- ONC201Â (in trials) may be cheaper but less proven.
- Medical Tourism
- Some countries offer lower-cost care (e.g., Germany, India).
