Expanding Treatment Access
Making investigational medicines available to patients with serious conditions before regulatory approval — because waiting is not an option.
Compassionate Care
Patient-centered approach
- Case-by-case evaluation
- Global regulatory compliance
- Physician partnership
What Are Early Access Programs?
EAPs allow qualified patients to receive investigational therapy outside of clinical trials when traditional treatment options are not available.
Serious Condition
Patient has a serious or life-threatening condition requiring urgent care.
No Alternatives
No approved treatments exist or available options have been exhausted.
Trial Ineligible
Patient is ineligible for participation in ongoing clinical trials.
Risk-Benefit
Potential benefits outweigh known and potential risks of treatment.
Our Commitment to Early Access
Patient-Centred Approach
We evaluate early access requests on a case-by-case basis, with compassion and urgency.
Physician Partnership
All requests must come through a licensed treating physician who can manage treatment and monitor conditions.
Global Compliance
Our EAPs comply with relevant national and regional laws, regulations, and ethical guidelines.
Who Can Request Early Access?
Treating Physicians
Licensed physicians can submit requests on behalf of their patients who meet eligibility criteria.
Healthcare Institutions
Medical institutions participating in our EAP partnerships can request access for eligible patients.
Eligibility Criteria
- Confirmed diagnosis of a disease targeted by our investigational therapy
- No access to comparable or satisfactory alternative treatment
- Inability to participate in relevant ongoing clinical trials
- Sufficient clinical data suggesting potential benefit for the patient's condition
How to Request Early Access
A simple 4-step process designed for efficiency and patient care
Physician Consultation
The treating physician contacts Dawn Therapeutics Medical Affairs to discuss potential eligibility.
Medical Documentation
Physician provides medical history, diagnosis confirmation, and treatment rationale.
Review Process
Our medical team evaluates the request, balancing safety, availability, and regulatory requirements.
Decision & Next Steps
Approved requests proceed with coordination between all parties and regulatory bodies.
Ready to Submit a Request?
Contact our Medical Affairs team to begin the early access process
- eap@dawntherapeutics.com
Transparency & Regulatory Registration
In keeping with our commitment to transparency, Dawn Therapeutics registers all open Early Access Programs on ClinicalTrials.gov and other regional registries where applicable.
Registry Compliance
All programs are publicly registered for complete transparency and regulatory compliance.
Important Disclaimer
Participation in an Early Access Program does not guarantee clinical benefit. These programmes are intended to provide potential therapeutic options when no satisfactory alternatives exist, and all treatments are administered under careful medical supervision.
Dawn Therapeutics
Because waiting is not an option for those who need hope today.