This section highlights FDA-related milestones and regulatory updates for drugs developed by Neonc Technologies (NTHI).
Over the past two years, Neonc Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NEO100, NEO100-01, and NEO212. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NEO100 FDA Regulatory Events
NEO100 is a drug developed by Neonc Technologies for the following indication: In Treatment of Pediatric-Type Diffuse High-Grade Gliomas.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NEO100
- Announced Date:
- March 31, 2025
- Indication:
- In Treatment of Pediatric-Type Diffuse High-Grade Gliomas
Announcement
NeOnc Technologies Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to perillyl alcohol (NEO100™) for the treatment of pediatric-type diffuse high-grade gliomas, a serious and life-threatening condition affecting children and adolescents.
AI Summary
NeOnc Technologies Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for its drug candidate perillyl alcohol (NEO100™). This designation is aimed at treating pediatric-type diffuse high-grade gliomas, a severe and life-threatening brain cancer affecting children and adolescents. The FDA’s decision highlights the urgent need for effective therapies since this aggressive form of glioma primarily impacts individuals from birth to 18 years of age and is considered a rare condition under the law. With the RPDD status, NeOnc becomes eligible for a Rare Pediatric Disease Priority Review Voucher, which could help expedite the drug’s regulatory review process if it receives approval. NeOnc sees this milestone as a significant step forward in developing innovative treatment options, offering renewed hope for improved outcomes for young patients and their families.
Read Announcement
NEO100-01 FDA Regulatory Events
NEO100-01 is a drug developed by Neonc Technologies for the following indication: For Brain Cancer Treatments.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NEO100-01
- Announced Date:
- April 14, 2025
- Indication:
- For Brain Cancer Treatments
Announcement
NeOnc Technologies announced that Trial Read-Out Data Expected in Early 2026
AI Summary
NeOnc Technologies announced that it expects to complete enrollment in its Phase 2a clinical trial for its lead candidate, NEO100-01, by September. Only six patients remain to reach the goal of 25 participants. The trial is focused on treating central nervous system cancers, especially malignant gliomas, by using a unique intranasal delivery of a highly purified form of perillyl alcohol. This method is designed to bypass the blood-brain barrier and may help improve the treatment of aggressive brain tumors.
The company has set an exciting milestone, expecting to deliver the full trial read-out data in early 2026. This data will be key in determining the treatment's effectiveness and overall safety, and it could have significant implications for patients battling severe brain cancers. NeOnc Technologies remains optimistic about the potential impact of this innovative approach on patient outcomes.
Read Announcement- Drug:
- NEO100-01
- Announced Date:
- April 14, 2025
- Indication:
- For Brain Cancer Treatments
Announcement
NeOnc Technologies announced that it expects full enrollment in its Phase 2a clinical trial for its lead therapeutic candidate, NEO100-01 in September. Only six patients remain to complete the trial's 25-patient enrollment target.
AI Summary
NeOnc Technologies has announced an important milestone in its research efforts against aggressive brain cancers. The company expects to reach full enrollment of its Phase 2a clinical trial for its lead candidate, NEO100-01, by September. With only six patients remaining to meet the 25-patient target, the trial is quickly moving forward. NEO100-01 is an innovative, highly purified version of perillyl alcohol delivered intranasally—a non-invasive method designed to bypass the blood-brain barrier. The study will evaluate the treatment’s safety and effectiveness for patients facing aggressive central nervous system cancers, with trial data expected to be released in early 2026. This progress in patient enrollment underscores the company’s commitment to developing novel therapeutic approaches and may pave the way for future breakthroughs in addressing challenging brain tumors.
Read Announcement- Drug:
- NEO100-01
- Announced Date:
- March 27, 2025
- Indication:
- For Brain Cancer Treatments
Announcement
NeOnc Technologies Holdings announced a strategic partnership with CBCC Global Research (CBCC), a premier full-service clinical research organization (CRO).
AI Summary
NeOnc Technologies Holdings announced a strategic partnership with CBCC Global Research, a leading clinical research organization. This collaboration aims to boost NeOnc’s clinical trial capabilities in India, where the company will initiate trials at 30 FDA-compliant research sites. The partnership is set to support the launch of the Phase 2a NEO100-01 trial, which is testing a novel intranasal therapy for aggressive brain tumors, including glioblastoma. By teaming up with CBCC, NeOnc expects to accelerate patient enrollment, maintain rigorous regulatory standards, and streamline trial operations through a combined network in India and coordination with its U.S.-based CRO, Anova Enterprises.
This move underlines NeOnc’s commitment to advancing innovative neuro-oncology treatments and expands its reach to a more diverse patient population, potentially speeding up the development and approval process for a promising new therapy.
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NEO212 FDA Regulatory Events
NEO212 is a drug developed by Neonc Technologies for the following indication: For Brain Cancer Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NEO212
- Announced Date:
- April 8, 2025
- Indication:
- For Brain Cancer Therapy
Announcement
NeOnc Technologies Holdings, Inc announced that its Phase I clinical trial of NEO212, a development-stage bio-conjugated therapeutic for brain cancer, is nearing full enrollment. The final cohort (Cohort 5) is expected to complete the study's dosing protocol, marking a major milestone in the drug's development timeline.
AI Summary
NeOnc Technologies Holdings, Inc. announced that the Phase I clinical trial for their development-stage bio-conjugated brain cancer therapy, NEO212, is almost fully enrolled. The drug, which is a new combination of temozolomide and perillyl alcohol, aims to improve treatment effectiveness for brain cancer by addressing some of the limitations of standard chemotherapy. Its design ensures improved stability and oral bioavailability, potentially reaching tumors with fewer systemic side effects.
The trial is structured into five escalating cohorts, with the final group—Cohort 5—expected to complete the study’s dosing protocol soon. This marks a major milestone in the development timeline for NEO212, advancing the therapeutic candidate closer to potential future clinical application and bringing hope for improved treatment options in brain and central nervous system cancers.
Read Announcement
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