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
NEO212, NEO212-01, NEO100-01, and NEO100. 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.
NEO212 FDA Regulatory Timeline and 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:
- March 4, 2026
- Indication:
- For Brain Cancer Therapy
Announcement
NeOnc Technologies announced data from the dose-escalation portion of its Phase 1/2 clinical trial for NEO212, the Company's novel oral bio-conjugated therapy and will host a conference call to discuss the data today at 9:00am ET.
AI Summary
NeOnc Technologies announced data from the dose-escalation portion of its Phase 1/2 trial for NEO212, its novel oral bio‑conjugated therapy. The study reached a maximum tolerated dose at Cohort 5 (810 mg, Days 1–5 of a 28‑day cycle) after a second dose‑limiting toxicity, so dose escalation has been halted. The company set the Recommended Phase 2 Dose (RP2D) at 610 mg (Cohort 4). For the Phase 2a metastasis cohort, the planned starting dose is 400 mg (Cohort 3).
Although Phase 1 focused on safety and tolerability, investigators observed encouraging signs of clinical efficacy, including lasting disease control in heavily pretreated patients with recurrent glioblastoma and brain metastases. These early anti‑tumor signals support advancing into the Phase 2 portion to further assess efficacy at the RP2D. NeOnc will host a conference call to discuss the data today at 9:00am ET.
Read Announcement- Drug:
- NEO212
- Announced Date:
- September 10, 2025
- Indication:
- For Brain Cancer Therapy
Announcement
NeOnc Technologies announced that the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial.
AI Summary
NeOnc Technologies announced that the U.S. Food and Drug Administration has authorized the company to begin Phase IIa/IIb of its NEO212-01 clinical trial. This decision follows a successful Phase I dose-escalation study, which showed NEO212 can be safely given at doses up to 810 mg per day on Days 1–5 of a 28-day cycle. An independent review of the Phase II dose is underway, and patient enrollment is expected to start before the end of 2025.
NEO212 is an oral, next-generation chemotherapy conjugate that merges temozolomide (the current standard for glioblastoma) with a proprietary form of perillyl alcohol. This design aims to improve blood-brain barrier penetration, overcome resistance, and boost antitumor activity. NeOnc believes NEO212 could replace temozolomide as the future standard of care for brain cancers.
In Phase II, NeOnc will expand patient enrollment at leading U.S. cancer centers. The trial will build on four active sites and prepare activation at a broad network of premier institutions, paving the way for broader testing and potential approval.
Read Announcement- 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
NEO212-01 FDA Regulatory Events
NEO212-01 is a drug developed by Neonc Technologies for the following indication: In Oral Formulation For Patients With CNS Malignancies.
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:
- NEO212-01
- Announced Date:
- February 27, 2026
- Indication:
- In Oral Formulation For Patients With CNS Malignancies
Announcement
NeOnc Technologies Holdings, Inc. announced today announced that it will host an investor conference call and webcast on March 4, 2026, at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time.
AI Summary
NeOnc Technologies Holdings, Inc. will host an investor conference call and webcast on March 4, 2026, at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time. Members of NeOnc’s management team and independent members of the company’s Scientific Advisory Board will present initial data from the Phase 1 dose‑escalation portion of the NEO212‑01 Phase 1/2 clinical trial.
NEO212‑01 evaluates NeOnc’s proprietary bioconjugated temozolomide (TMZ) oral formulation for patients with central nervous system malignancies. The discussion will cover safety and toxicity data, dose‑escalation observations, pharmacokinetic findings, and planned regulatory next steps informed by these early results.
The call will be webcast for investors and interested parties. For webcast access, replay details, and more information about the trial and the company, visit NeOnc’s website or contact the company’s investor relations team.
Read Announcement
NEO100-01 FDA Regulatory Timeline and 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:
- November 13, 2025
- Indication:
- For Brain Cancer Treatments
Announcement
NeOnc Technologies announced the completion of full patient enrollment in its ongoing NEO100-1 Phase 2a clinical trial.
AI Summary
NeOnc Technologies announced it has completed full patient enrollment in its NEO100-1 Phase 2a clinical trial. The study is testing NEO100, an intranasal therapy, in people with recurrent IDH1‑mutant high‑grade glioma (WHO Grade III and IV). Completing enrollment lets the company evaluate the drug across the full planned patient group.
The company said it expects to report preliminary data from the fully enrolled cohort in about six months, during the second quarter of 2026. Management described finishing enrollment as a key inflection point that follows encouraging interim results and positions the program for its next clinical milestone.
NeOnc highlighted that NEO100’s intranasal delivery is designed to bypass the blood‑brain barrier and has shown early signs of radiographic remission and durable survival in some patients. The upcoming data readout will be important for assessing the therapy’s potential and the program’s future direction.
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:
- 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:
- 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.
Read Announcement
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:
- November 12, 2025
- Indication:
- In Treatment of Pediatric-Type Diffuse High-Grade Gliomas
Announcement
NeOnc Technologies Holdings, Inc announced updated clinical results from its current Phase 1/2a and compassionate care studies involving a cohort of 24 patients with recurrent WHO Grade III/IV isocitrate dehydrogenase 1 (IDH1)–mutant astrocytoma treated with its investigational intranasal agent, NEO100.
AI Summary
NeOnc Technologies reported updated results from its combined Phase 1/2a and compassionate-use studies of intranasal NEO100 in 24 patients with recurrent WHO Grade III/IV IDH1‑mutant astrocytoma. Patients received daily intranasal NEO100 and responses were evaluated by contrast‑enhanced, T2‑FLAIR and perfusion MRI using RANO criteria.
Five of 24 patients (21%) achieved a significant radiographic response, a rate that the company says is well above the <8% typically seen with salvage therapies for recurrent gliomas. Six‑month progression‑free survival (PFS‑6) was 44%, compared with historical benchmarks of about 21–31% for similar IDH1‑mutant tumors. Long‑term survival was notable: 8 of 24 patients (33%) were alive at or beyond 18 months after starting NEO100.
No significant toxicity was reported, even with prolonged intranasal use. The combined analysis included one compassionate‑use case, five Phase 1 and 18 Phase 2a patients enrolled at least six months before the data cutoff, supporting further study of NEO100.
Read Announcement- 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
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