Aphios Corporation, a leading innovator in botanical pharmaceuticals, green chemistry, and biotechnology, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Center for Complementary & Integrative Health (NCCIH) at the National Institutes of Health (NIH). This competitive federal grant will support the continued development of Zindol®, a next-generation botanical drug candidate derived from ginger (Zingiber officinale) for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV)—a persistent, distressing side effect experienced by a majority of cancer patients.
Addressing a Persistent and Devastating Side Effect of Chemotherapy
CINV is among the most common and feared side effects of cancer treatment, affecting up to 70% of adult patients receiving highly emetogenic chemotherapy drugs. While pharmaceutical options such as 5-HT3 and NK-1 receptor antagonists have improved symptom control over the past few decades, many patients continue to experience breakthrough or delayed nausea and vomiting that standard medications fail to address.
These ongoing symptoms not only compromise patients’ quality of life but can also lead to treatment noncompliance, with some patients delaying or refusing further chemotherapy cycles due to the severity of their side effects. Such interruptions can have life-threatening consequences, underscoring the urgent need for more effective, better-tolerated antiemetic therapies.
Zindol®: A Botanical Solution Rooted in Science
Zindol® represents a breakthrough in botanical drug development—an advanced, pharmaceutical-grade formulation derived from ginger using Aphios’ proprietary SuperFluids™ extraction technology. This patented process isolates the plant’s bioactive compounds, primarily gingerols and shogaols, in a highly purified and stable form, ensuring >90% purity and precise dosage consistency—something not achievable with traditional herbal extracts.
Ginger has long been recognized for its anti-nausea and digestive benefits in traditional medicine, but Aphios has transformed this ancient remedy into a modern, science-backed drug candidate that meets FDA botanical drug development standards.
Earlier clinical studies using Aphios’ first-generation formulation, Zindol® DS (approximately 30% purity), demonstrated remarkable clinical efficacy. In trials involving more than 600 cancer patients, Zindol® DS significantly reduced nausea (p=0.003) and outperformed the standard antiemetic Zofran® (Ondansetron)—a widely prescribed pharmaceutical—without adverse side effects.
In addition to its efficacy in cancer patients, Zindol® DS showed promising results in motion sickness, morning sickness, post-surgical nausea, and drug-induced nausea (including from GLP-1 agonists used in obesity treatment). It has even been safely used by pregnant women, reinforcing its broad potential and excellent safety profile.
Advancing Toward Clinical Trials and Market Readiness
With this latest NIH SBIR Phase I award, Aphios will advance the development of a next-generation formulation of Zindol® that achieves higher purity and greater pharmacological consistency. The Phase I research program will focus on:
- Enhancing purification and formulation of Zindol® to achieve >90% concentration of active gingerols and shogaols.
- Establishing product stability, release specifications, and batch reproducibility to meet FDA standards.
- Evaluating biological activity using Aphios’ proprietary in vitro nausea assay, which provides a predictive model for clinical antiemetic efficacy.
“We are honored to receive this highly competitive NIH award, which validates both the scientific promise and therapeutic potential of Zindol®,” said Dr. Trevor P. Castor, PhD, President, Founder, and CEO of Aphios Corporation, who serves as the project’s Principal Investigator. “This grant allows us to advance Zindol® toward clinical trials and ultimately deliver a safe, effective, and natural therapeutic option for cancer and obesity patients who struggle with severe nausea and vomiting.”
Dr. Castor added, “Zindol® is derived entirely from a common food spice—ginger—but represents an advanced, standardized drug formulation built on rigorous pharmaceutical science. Our goal is to bridge the gap between traditional medicine and modern pharmacology to improve lives in a sustainable, evidence-based way.”
Clinical and Commercial Potential
If ongoing development efforts continue to mirror the strong outcomes observed in prior research, Zindol® could significantly change the landscape of supportive oncology care. The drug’s potential benefits include:
- Replacing or reducing reliance on combinations of synthetic antiemetics, minimizing side effects such as constipation, headaches, or sedation.
- Lowering treatment costs by providing a natural, effective alternative to multi-drug regimens.
- Enhancing patient adherence to chemotherapy through better nausea control and improved tolerability.
- Improving overall quality of life for millions of patients undergoing cancer treatment or using medications that trigger nausea.
Beyond oncology, Zindol® may also find applications in obesity management, where many patients experience nausea from GLP-1 agonists such as semaglutide. This cross-indication potential further strengthens Zindol®’s commercial value and aligns with the growing demand for safer, natural-based therapeutics in modern medicine.
A Strategic Path Toward FDA Approval and Partnerships
Following successful completion of the Phase I SBIR objectives, Aphios intends to pursue Phase II IND-enabling toxicology studies and later Phase III clinical trials to confirm efficacy and safety in cancer and obesity patient populations.
Ultimately, the company plans to license Zindol® to a strategic pharmaceutical partner for large-scale commercialization. With an estimated $3.4 billion global antiemetics market currently dominated by synthetic drugs—and no botanical alternatives meeting pharmaceutical-grade standards—Zindol® is poised to fill a significant gap.
“We believe Zindol® has the potential to become the first FDA-approved botanical drug for chemotherapy-induced nausea and vomiting,” said Dr. Castor. “This would not only validate our technology platform but also deliver meaningful benefits to patients who have limited effective options today.”
A Legacy of Innovation in Botanical Drug Development
Aphios Corporation has been at the forefront of developing green, sustainable, and high-performance pharmaceutical technologies for more than two decades. The company’s proprietary SuperFluids™ technology uses environmentally friendly supercritical fluids and near-critical fluids for the extraction and purification of biologically active compounds, preserving their potency and eliminating toxic residues.
This technology underpins a robust pipeline of botanical drug candidates targeting cancer, neurodegenerative diseases (such as Alzheimer’s), viral infections, and pain management. Aphios’ innovative approach to natural product drug development aligns with a broader global shift toward cleaner, sustainable, and science-validated therapies.
Looking Ahead
With NIH’s continued support, Aphios is now well-positioned to bring Zindol® closer to the clinic and, ultimately, to the patients who need it most. The company’s work exemplifies the power of integrating traditional natural medicine with cutting-edge biotechnology—offering hope for safer, more effective treatments for some of medicine’s most challenging side effects.
“Every patient who completes their chemotherapy without fear of nausea is a victory,” concluded Dr. Castor. “Our mission is to make that victory possible for every cancer and obesity patient worldwide.”
