Astex SGI-110 guadecitabine MDS investigational

Indicated For

Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), CMML

About This Medication

# Guadecitabine Patient Guide: How to Get Guadecitabine at Low or No Cost **Important Notice:** Guadecitabine (SGI-110) is an investigational drug developed by Astex Pharmaceuticals, a member of the Otsuka group of companies. It is **not currently FDA-approved** for commercial use and is only available through clinical trials or compassionate use programs, if any exist[1][2][7][9]. There is no standard patient assistance program (PAP) for guadecitabine because it has not progressed to market approval following disappointing Phase 3 trial results (ASTRAL-1, ASTRAL-2, ASTRAL-3), which failed to meet primary endpoints for survival in AML and MDS patients[1][7]. This guide provides general information on accessing investigational therapies and alternatives for patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Always consult your oncologist for personalized advice. ## About Guadecitabine Guadecitabine is a next-generation hypomethylating agent (HMA), a small molecule dinucleotide of decitabine designed for subcutaneous administration. It works by inhibiting DNA methyltransferases, potentially reactivating tumor suppressor genes silenced in cancers like AML and MDS[2][5][8][9]. Clinical studies showed promising early activity: Phase 1/2 trials demonstrated tolerability at 60 mg/m² daily for 5 days, with responses in treatment-naïve and relapsed/refractory AML/MDS patients[5][9]. It received FDA Orphan Drug Designation for AML, recognizing its potential for rare diseases affecting fewer than 200,000 US patients[2][9]. However, Phase 3 ASTRAL trials (2018-2020) did not show superior survival over standard treatments, halting further development for approval[1][7]. Ongoing or extension studies (e.g., NCT03603964) may still enroll eligible patients[3]. **Who might benefit?** Primarily adults with AML unfit for intensive chemotherapy or higher-risk MDS/CMML. It's been explored in combinations, like with atezolizumab (anti-PD-L1) for immune priming[4][10]. ## Who Qualifies for Access? Since there's no commercial PAP, access is limited to: - **Clinical trial participation**: Check ClinicalTrials.gov for Astex-sponsored studies (e.g., prior trials like SGI-110-01, ASTRAL series)[3]. - **Expanded access/compassionate use**: Contact Astex Pharmaceuticals directly if trials are unavailable. - **General financial need programs**: For approved HMAs like decitabine or azacitidine, low-income patients may qualify via manufacturer PAPs or state programs. **Income Eligibility**: No specific thresholds for guadecitabine PAP (none exists). For similar approved drugs, programs often use **400-500% of the Federal Poverty Level (FPL)**. Here's a general breakdown for reference (2026 FPL estimates; verify current guidelines): | Household Size | 400% FPL (Annual Income) | 500% FPL (Annual Income) | |----------------|---------------------------|---------------------------| | Individual | ~$60,000 | ~$75,000 | | Couple | ~$81,000 | ~$101,000 | | Family of 3 | ~$102,000 | ~$128,000 | | Family of 4 | ~$123,000 | ~$154,000 | *Notes: Eligibility varies; US citizenship/residency often required. Excludes most assets[general knowledge].* ## Insurance Requirements Guadecitabine isn't covered by insurance due to its investigational status. For approved alternatives: - Medicare Part D may cover HMAs but with high copays. - Commercial insurance often requires prior authorization. - PAPs typically require **no or limited coverage**; patients with government insurance (Medicare/Medicaid) may be ineligible for free drug but qualify for copay assistance. ## Step-by-Step Application Process 1. **Consult your doctor**: Discuss if guadecitabine or trials suit you. Search ClinicalTrials.gov for 'guadecitabine' or 'SGI-110'[3]. 2. **Contact manufacturer**: Reach Astex Pharmaceuticals (part of Otsuka) via their website (astx.com) or medical information line for expanded access inquiries. 3. **Prepare documents**: Prescription, proof of income (tax returns, pay stubs), ID, insurance details (if applicable). 4. **Apply to trials**: Submit via trial sites; no standard form. 5. **Explore alternatives**: Apply to PAPs for decitabine (e.g., Otsuka Patient Assistance) or azacitidine (Celgene/Co-pay programs). 6. **Follow up**: Track status weekly. ## Timeline and Delivery - **Trial enrollment**: 2-8 weeks from screening to first dose[3]. - **Compassionate use**: 4-12 weeks, if approved. - **Delivery**: Administered subcutaneously in clinics; no home delivery for investigational drugs. ## Alternatives if Denied or Ineligible - **Approved HMAs**: Decitabine (Dacogen®), azacitidine (Vidaza®) – similar mechanism, FDA-approved for MDS/AML. Check their PAPs. - **Other AML therapies**: Venetoclax + HMA combinations, low-intensity options. - **Financial aid**: NeedyMeds.org, RxAssist.org, PAN Foundation grants. - **Biosimilars**: None for guadecitabine[provided data]. - **Trials for alternatives**: Search for HMAs or AML studies. ## Refill and Reauthorization Trials have fixed durations; reauthorization via protocol amendments. No standard PAP refills. **Disclaimer:** This guide is for informational purposes only and not medical or legal advice. Guadecitabine's development status may change; verify with Astex/Otsuka. Access depends on eligibility and availability. Consult healthcare providers. Data based on public sources up to 2020; no active PAP confirmed[1][2]. (Word count: 912)

Program information last verified: March 30, 2026