Designing for Future Compassionate Use and Expanded Access
At Dawn Therapeutics, we are committed to establishing ethically designed Expanded Access / Early Access programmes once our investigational therapies advance toward clinical study. At present, no Early Access or compassionate use programmes are active, as all of our therapies remain in preclinical development.
What Are Early Access / Expanded Use Programs?
These programmes may allow patients with serious conditions to access investigational treatments outside of a clinical trial, under exceptional circumstances and at the discretion of regulatory authorities. They serve as a bridge between the laboratory and formal clinical trials, but are not a substitute for clinical study participation.
Compassionate Care
Patient-centered approach
- Case-by-case evaluation
- Global regulatory compliance
- Physician partnership
Our Approach to Future Early Access
As we move closer to human studies, Dawn Therapeutics plans to adopt a responsible and transparent access strategy built on these principles:
Strict eligibility criteria
aligned with regulatory guidance and clinical ethics
Case-by-case evaluation
through an independent medical review process
Physician-led requests only
all proposals must come from licensed treating physicians
Compliance with regional laws and oversight
including institutional review boards and regulatory authorities
Clear transparency and registry
once active, access programmes will be publicly listed and documented
What This Page Is For
Inform & Educate:
To inform the public, patients, and clinical partners about Dawn’s early access philosophy and roadmap.
Demonstrate Commitment:
To show our dedication to transparency, equity, and ethical practice as future programmes are implemented.
Stay Connected:
To collect non-binding interest registrations from patients, families, or physicians who wish to receive updates once programmes become available.
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.
Stay Informed
Although we are not accepting requests at this time, you can:
- Sign up for updates — get notified when an Early Access programme becomes open
- Reach out to our Medical Affairs team for general information (not individual access)
- Keep an eye on this page — future programmes, eligibility guidelines, and application processes will be posted here
Review related clinical programme info on our Clinical Trials page
Why We Do This
A simple 4-step process designed for efficiency and patient care
Compassionate Framework:
To provide a structure for ethical access to investigational therapies when no approved options exist.
Fairness & Oversight:
To uphold equity, medical ethics, and proper review in exceptional cases.
Transparency & Accountability:
To ensure openness and clarity in how access decisions are made.
Safety as Priority:
To guarantee that any access outside formal trials is conducted with rigorous safety monitoring and regulatory alignment.
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.
Disclaimer & Transparency
All descriptions, plans, or statements about Early Access or Expanded Use programmes are forward-looking and intend for future implementation, not current provision. Any access to investigational therapies will always comply with applicable regulatory requirements, ethics oversight, and informed consent standards. We do not guarantee approval for access, nor do program plans imply therapeutic benefit or safety.
Dawn Therapeutics
Because waiting is not an option for those who need hope today.
