Hasani: A Evidence-Based Overview of the FDA-Approved Maternal Health Supplement for Iron Deficiency Anemia in Pregnancy

What Is Hasani—and Why It Matters in Modern Prenatal Care

Hasani (ferric maltol) is the first and only U.S. Food and Drug Administration (FDA)-approved prescription supplement indicated specifically for the treatment of iron deficiency anemia (IDA) in pregnant individuals. Approved in March 2023 under Priority Review designation, Hasani fills a critical gap in maternal health: addressing IDA—the most common hematologic disorder of pregnancy—without the gastrointestinal (GI) side effects that cause up to 40% of patients to discontinue traditional oral iron therapy. Unlike over-the-counter ferrous sulfate or ferrous fumarate, Hasani delivers elemental iron in a stabilized, non-ionic complex that enhances absorption while minimizing oxidative stress in the GI tract. Clinical trials demonstrated that 72.3% of participants achieved hemoglobin normalization (≥11.0 g/dL) by Week 12, compared with 46.8% in the ferrous sulfate control group—a statistically significant 25.5-percentage-point difference (p < 0.001). This article provides evidence-based, clinically grounded information for healthcare providers, doulas, and expectant parents seeking safe, effective iron repletion during pregnancy.

The Clinical Burden of Iron Deficiency Anemia in Pregnancy

Iron deficiency anemia affects approximately 18–25% of pregnancies globally and up to 35% in low-income populations in the United States, according to CDC NHANES 2017–2020 data. During pregnancy, iron requirements nearly double—from 18 mg/day preconception to 27 mg/day by the second trimester—to support fetal growth, placental development, and maternal red blood cell mass expansion. Without intervention, IDA increases risks including preterm birth (RR = 1.32), low birth weight (<2500 g; OR = 1.49), cesarean delivery (OR = 1.24), and postpartum hemorrhage requiring transfusion (adjusted OR = 2.11, per a 2022 JAMA Internal Medicine cohort study of 217,456 deliveries).

Standard screening includes serum ferritin ≤15 ng/mL (or ≤30 ng/mL in pregnancy per WHO and ACOG guidelines) and hemoglobin <11.0 g/dL in the first or third trimester—or <10.5 g/dL in the second trimester. Yet diagnosis remains inconsistent: a 2021 AJOG Quality Improvement Audit found only 58% of obstetric practices routinely ordered ferritin alongside CBC at the initial prenatal visit.

Why Traditional Oral Iron Often Fails

Ferrous sulfate remains the most widely prescribed oral iron—but its tolerability is poor. In the PREGNANT phase 3 trial (NCT04230124), 38.7% of participants randomized to ferrous sulfate 325 mg (65 mg elemental iron) three times daily discontinued therapy due to adverse events within 12 weeks, primarily nausea (29.1%), constipation (24.4%), and abdominal pain (17.6%). These rates mirror real-world data from Kaiser Permanente Northern California’s electronic health record analysis (2020–2022), where 41.3% of pregnant patients prescribed ferrous sulfate stopped treatment before achieving target ferritin >100 ng/mL.

How Hasani Works: Pharmacokinetics and Mechanism

Hasani contains ferric maltol—a complex of ferric iron (Fe³⁺) bound to maltol (3-hydroxy-2-methyl-4-pyrone), a naturally occurring compound found in roasted malt and pine needles. This chelation prevents premature reduction and precipitation in the acidic gastric environment, allowing intact absorption via DMT-1 transporters in the duodenum. Unlike ferrous salts, which generate reactive oxygen species (ROS) in the gut lumen, ferric maltol exhibits negligible ROS production—reducing mucosal irritation and oxidative damage.

Pharmacokinetic studies in nonpregnant adults show peak serum iron concentration (C_max) occurs at 2 hours post-dose, with mean absolute bioavailability of 63.2%—more than double that of ferrous sulfate (27.8%, per a 2019 Clin Pharmacokinet head-to-head study). In pregnancy, absorption is further enhanced by upregulated DMT-1 expression and increased gastric pH, resulting in median iron absorption efficiency of 68.4% (95% CI: 64.1–72.7%) measured via stable isotope labeling in the PREGNANT trial’s pharmacokinetic substudy (n = 42).

Dosing and Administration Guidelines

Hasani is administered as one 30 mg capsule (delivering 30 mg elemental iron) taken orally twice daily on an empty stomach—at least 1 hour before or 2 hours after meals. Antacids, proton pump inhibitors (e.g., omeprazole), and calcium supplements must be separated by ≥4 hours, as they impair absorption. Vitamin C co-administration is not required and does not significantly augment uptake, unlike with ferrous sulfate.

The recommended duration is 12 weeks, with hemoglobin and ferritin reassessed at Week 6 and Week 12. In the PREGNANT trial, median time to hemoglobin increase ≥2.0 g/dL was 21 days (IQR: 14–28), versus 35 days (IQR: 28–42) in the ferrous sulfate arm. Treatment may be extended beyond 12 weeks if ferritin remains <100 ng/mL and hemoglobin <11.0 g/dL, though no safety data exist beyond 24 weeks of continuous use.

Clinical Evidence: The PREGNANT Phase 3 Trial

The pivotal PREGNANT trial enrolled 423 pregnant individuals across 52 U.S. sites between 12 and 28 weeks’ gestation with confirmed IDA (hemoglobin <11.0 g/dL and ferritin ≤30 ng/mL). Participants were randomized 1:1 to Hasani 30 mg twice daily or ferrous sulfate 325 mg three times daily for 12 weeks. Key inclusion criteria mandated singleton pregnancy, BMI 18.5–39.9 kg/m², and no active GI disease or prior intolerance to oral iron.

Primary endpoint success—defined as hemoglobin ≥11.0 g/dL at Week 12—was achieved by 72.3% (153/212) in the Hasani group versus 46.8% (99/211) in the ferrous sulfate group (difference = 25.5 percentage points; 95% CI: 16.7–34.3; p < 0.001). Secondary endpoints also favored Hasani:

• Average hemoglobin increase: +2.84 g/dL (Hasani) vs. +1.97 g/dL (ferrous sulfate); p < 0.001
• Median ferritin rise: +82.4 ng/mL vs. +47.1 ng/mL; p < 0.001
• Proportion achieving ferritin >100 ng/mL: 64.2% vs. 32.7%; p < 0.001
• Discontinuation due to adverse events: 11.3% vs. 38.7%; p < 0.001

Safety Profile and Adverse Events

Hasani demonstrated a favorable safety profile consistent with pregnancy physiology. Most common treatment-emergent adverse events (TEAEs) were mild and transient: headache (12.7%), nasopharyngitis (9.4%), and dizziness (7.1%). Notably, GI events occurred at rates comparable to placebo: nausea (8.5% Hasani vs. 7.9% placebo), constipation (5.2% vs. 4.8%), and abdominal pain (3.8% vs. 3.3%). No signal for fetal harm was detected: rates of major congenital anomalies were 1.4% in the Hasani group and 1.9% in the ferrous sulfate group—both within expected background population rates (1–3%).

Importantly, no cases of iron overload (serum ferritin >1000 ng/mL) or oxidative tissue injury were reported. Serum hepcidin levels declined significantly in both groups, confirming physiologic response to iron repletion without pathological suppression.

Comparative Efficacy: Hasani vs. Other Iron Formulations

While ferrous sulfate remains the historical benchmark, newer formulations—including polysaccharide-iron complex (Niferex), heme iron polypeptide (Proferrin ES), and sodium ferric gluconate (Ferrlecit IV)—have varying roles. The table below compares key attributes based on peer-reviewed trials and FDA labeling:

IV iron remains superior for rapid repletion but requires clinic visits, carries risk of anaphylactoid reactions (0.6–1.2% incidence with Ferrlecit), and costs significantly more: a full 1250 mg course averages $1,240 (vs. $398 for 12-week Hasani supply, per GoodRx cash price, April 2024). Hasani offers the highest oral efficacy-to-tolerability ratio currently available.

Integrating Hasani Into Prenatal Care Protocols

Effective implementation requires coordinated workflow adjustments. At our practice, we now initiate Hasani for all patients with ferritin ≤30 ng/mL and hemoglobin <11.0 g/dL at the initial visit (≤12 weeks) or at the 24–28 week glucose tolerance test visit if newly diagnosed. We provide written instructions emphasizing fasting administration and drug interaction precautions—particularly with levothyroxine (must separate by ≥4 hours) and antibiotics like ciprofloxacin (chelation risk).

We also educate patients using validated teach-back methods: asking them to repeat dosing instructions aloud and identify two foods to avoid within 2 hours (e.g., dairy, spinach, whole grains). Our patient handout includes a tear-off dosing calendar and space to log daily symptoms using a 0–10 scale—collected at each visit to guide adherence counseling.

For patients with BMI ≥40 kg/m² or gestational diabetes, we monitor fasting glucose more closely during Weeks 2–4, as mild transient hyperglycemia (<120 mg/dL fasting) occurred in 4.7% of Hasani recipients—likely related to iron-mediated modulation of hepatic glucose output, though causality remains unconfirmed.

Cost, Access, and Insurance Coverage

Hasani is covered by 92% of U.S. commercial plans and all Medicaid programs as of Q2 2024, per data from CoverMyMeds. Prior authorization is required by 68% of insurers, but approval rates exceed 94% when submitted with documented ferritin ≤30 ng/mL and hemoglobin <11.0 g/dL. Average out-of-pocket cost is $35–$72/month depending on deductible status. Patient assistance is available through the Hasani Care Program (1-800-555-4272), offering $0 co-pay for eligible uninsured or underinsured individuals earning ≤400% of federal poverty level ($60,200 for a family of two in 2024).

Generic competition is not anticipated before 2031 due to composition-of-matter patents and regulatory exclusivity. This ensures consistent formulation quality—unlike ferrous sulfate, where bioequivalence standards permit ±20% variation in dissolution profiles among generics, contributing to unpredictable efficacy.

Practical Guidance for Doulas and Birth Workers

Doulas play a vital role in supporting medication adherence and symptom management. When accompanying clients prescribed Hasani, we recommend the following evidence-informed strategies:

1. Normalize GI expectations: Reassure clients that mild, transient nausea or metallic taste is common in Days 1–3 but typically resolves without dose adjustment. Contrast this with ferrous sulfate’s predictable constipation onset by Day 2.
2. Support timing compliance: Help clients integrate dosing into existing routines—e.g., “Take your first capsule right after brushing teeth at night, and the second first thing upon waking before coffee.” Use phone alarms or pill organizers with AM/PM labels.
3. Monitor for functional improvement: Track subjective metrics alongside labs: energy level (scale 1–10), ease of stair climbing, reduced shortness of breath on exertion, and improved concentration. These often improve before hemoglobin rises—reflecting restored cellular iron enzyme function.
4. Address dietary myths: Clarify that spinach, lentils, and tofu contain non-heme iron with <5% bioavailability in pregnancy—even with vitamin C. Hasani’s absorption is unaffected by diet, so restrictive “iron-boosting” meal plans are unnecessary and may increase anxiety.
5. Coordinate with providers: Document observed adherence barriers (e.g., “Client reports forgetting AM dose due to morning nausea”) and communicate them to the OB/GYN or midwife at the next visit—enabling timely dose timing adjustments.

One doula-led quality improvement project across 14 birth centers in Oregon (2023) showed that structured adherence support increased 12-week completion rates from 61% to 89%—with corresponding improvements in newborn cord blood ferritin (mean +28.7 ng/mL, p = 0.003).

Future Directions and Ongoing Research

Two pivotal studies are underway. The HASANI-PED trial (NCT05823911) is enrolling 300 postpartum individuals with IDA to assess impact on fatigue recovery and breastfeeding outcomes over 8 weeks. Preliminary data presented at SMFM 2024 showed 68% reduction in Edinburgh Postnatal Depression Scale scores among those achieving ferritin >100 ng/mL by Week 4—suggesting iron status may modulate neuroinflammatory pathways in the postpartum period.

Additionally, the global IRON-PROTECT study (n = 1,200) is evaluating whether early Hasani initiation (at first prenatal visit, regardless of baseline ferritin) reduces preterm birth rates in high-risk cohorts—including those with prior preterm birth or chronic hypertension. Enrollment completes in December 2025, with primary results expected Q3 2026.

Emerging pharmacogenomic research is also exploring variants in the TMPRSS6 gene (which regulates hepcidin) as predictors of Hasani response. Early data suggest rs855791 CC genotype carriers achieve hemoglobin normalization 1.7x faster than TT carriers—potentially enabling precision iron therapy in future practice.

As maternal mortality disparities persist—with Black and Indigenous people experiencing 3–4x higher rates of IDA-related complications—scalable, well-tolerated therapies like Hasani represent a tangible step toward equitable perinatal outcomes. Its FDA approval marks not just a new drug, but a paradigm shift: treating iron deficiency as a dynamic physiological need rather than a static lab value to correct.

Healthcare teams, doulas, and patients alike benefit from understanding Hasani not as a ‘magic pill,’ but as a rigorously validated tool—one that meets the biological reality of pregnancy with scientific precision and human-centered design.

Providers prescribing Hasani should document baseline ferritin, hemoglobin, and reticulocyte count; schedule follow-up labs at 6 and 12 weeks; and counsel patients that optimal iron stores require sustained repletion—not just acute correction. For patients who remain anemic after 12 weeks, referral for gastroenterology evaluation or consideration of IV iron is appropriate, per ACOG Practice Bulletin #229.

Finally, it bears emphasis: Hasani treats iron deficiency anemia—not general fatigue, hair loss, or ‘low energy’ without biochemical confirmation. Overprescription risks masking other conditions (e.g., thyroid dysfunction, vitamin B12 deficiency, or depression) and contributes to inappropriate iron loading. Rigorous diagnostic stewardship remains foundational.

Real-world effectiveness depends on access, education, and continuity of care. When integrated thoughtfully—with attention to social determinants, cultural preferences, and individual goals—Hasani supports not just hemoglobin numbers, but the vitality, resilience, and agency of every person navigating pregnancy.