DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification With Nimorazole During Radiotherapy/Chemoradiotherapy of Squamous Cell Carcinoma of the Head and Neck.

Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).
In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been possible to discriminate more hypoxic tumours from less hypoxic tumours.
A hypoxia gene profile has shown to discriminate between responders and non-responders to nimorazole.
In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/- nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.

Start Date01 Sep 2016

Sponsor / Collaborator

Danish Head And Neck Cancer Group

CTRI/2017/09/009921

/ RecruitingPhase 2

A prospective study of therapeutic outcome in locally advanced Head and Neck Cancers treated with chemo-radiation and the hypoxic radio- sensitizer Nimorazole

Start Date04 Jan 2016

Sponsor / Collaborator

Amrita Institute of Medical Sciences

100 Clinical Results associated with Nimorazole

100 Translational Medicine associated with Nimorazole

100 Patents (Medical) associated with Nimorazole

198

Literatures (Medical) associated with Nimorazole

01 Jan 2026·RADIOTHERAPY AND ONCOLOGY

An international placebo-controlled randomized multicenter trial of nimorazole with accelerated chemo-radiotherapy for locally advanced HPV-negative squamous cell carcinoma of the head and neck (HNSCC)

Article

Author: Vulquin, Noémie ; Kaanders, Johannes ; Nuyts, Sandra ; Grégoire, Vincent ; Machiels, Jean-Pascal ; Doornaert, Patricia ; Overgaard, Jens ; Tao, Yungan ; Alsner, Jan

PURPOSE:

To evaluate the benefit of the hypoxic radiosensitizer nimorazole (NIM) with accelerated concomitant chemo-radiotherapy in patients with advanced squamous cell carcinoma of the head and neck (HNSCC).

MATERIALS AND METHODS:

Patients with stage III-IV laryngeal, hypopharyngeal or HPV-negative oropharyngeal SCC were randomized between NIM or placebo, given concomitantly with moderately accelerated chemo-radiotherapy delivered using IMRT (70 Gy in 6 weeks). Total cisplatin dose was 200 mg/m² either weekly (40 mg/m²) or 3-weekly (100 mg/m²). NIM/placebo was given with 1.2 mg/m² daily.

RESULTS:

Between Aug 2014 and Jan 2018, when the trial closed prematurely, a total of 194 patients (92 oropharynx, 59 hypopharynx and 43 larynx) were randomized (97 NIM, 97 placebo) out of 640 planned. Most patients had T3-T4 (76%) and N2-3 (66%) tumors. The three-year incidence of locoregional failure was 20.7% (95% Cl: 12.8-29.8) in the NIM arm and 33.8% (24.1-43.8) in the placebo arm. Corresponding disease specific survival were 76.7% and 74.3% and overall survival 62.4% and 61.5% for NIM and placebo, respectively. Multivariable analysis demonstrated significant locoregional benefit of NIM (adjusted HR 0.51; 95% Cl: 0.27-0.95) together with good WHO performance and weekly cisplatin. Compliance with treatment did not differ significantly depending on NIM/placebo allocation and cisplatin regimen, nor did treatment related morbidity except for acute nephrotoxicity which appeared to be higher in the 3-weekly cisplatin regimen.

CONCLUSION:

NIM improved locoregional control in advanced HPV-negative HNSCC, but without significant survival improvement. This finding underscore that hypoxic radiosensitization plays a role in chemo-radiotherapy for HNSCC. The incompleteness of the study precluded further detailed analysis.

01 Dec 2025·RADIOTHERAPY AND ONCOLOGY

Radiotherapy quality assurance of the prospective randomised EORTC-1219/DAHANCA-29 trial: an individual case review analysis

Article

Author: Fortpied, Catherine ; Alyamani, Najlaa ; Grégoire, Vincent ; Christiaens, Melissa ; Giralt, Jordi ; Hurkmans, Coen W ; Corning, Coreen ; Collette, Sandra ; Monti, Angelo F ; Abrunhosa-Branquinho, André ; Andratschke, Nicolaus ; Castadot, Pierre ; Stelmes, Jean-Jacques ; Grant, Warren ; Kazmierska, Joanna ; Tomsej, Milan ; Sharabiani, Marjan ; Bar-Deroma, Raquel ; Overgaard, Jens ; Weber, D-C ; Clementel, Enrico

BACKGROUND:

The EORTC-1219/DAHANCA-29 trial investigated whether adding nimorazole to accelerated radiotherapy (RT) and chemotherapy improves locoregional control of locally advanced head and neck cancer. As part of the trial's RT quality assurance (RTQA) program, individual case review (ICR) of RT plans was performed to assess protocol compliance and treatment planning quality.

MATERIALS AND METHODS:

Nineteen centers submitted RT plans for central review. The trial mandated prospective ICR (p-ICR) for the first five patients per institution, with subsequent plans reviewed retrospectively or as optional p-ICR. Plans were reviewed by radiation oncologists and medical physicists. Plans deemed unacceptable in p-ICR were resubmitted for review, whereas retrospective ICR (r-ICR) cases were reviewed once. Plans were categorized as "Acceptable as per protocol," "Acceptable variation," or "Unacceptable variation.".

RESULTS:

RT plans for all 194 randomized patients were reviewed, with 174p-ICRs and 44 r-ICRs. The delineation acceptability rate for p-ICR improved from 69% at the first submission to 93% at final review. p-ICR had an 18% higher acceptance rate (90%) compared to r-ICR (73%). Dose and plan acceptability remained high (97%) at both first and final submission, with minimal differences between p-ICR and r-ICR.

CONCLUSION:

P-ICR significantly improved CTV delineation quality, ensuring higher protocol compliance and treatment planning accuracy. p-ICRs are recommended for complex treatments, tailored to the performance of individual sites.

01 May 2025·DRUG DEVELOPMENT RESEARCH

Repurposing Nitroimidazoles: A New Frontier in Combatting Bacterial Virulence and Quorum Sensing via In Silico, In Vitro, and In Vivo Insights

Article

Author: Wael A. H. Hegazy ; Amr Selim Abu Lila ; Mohammed F. Aldawsari ; Ahmed Al Saqr ; Bjad K. Almutairy ; Tarek S. Ibrahim ; El‐Sayed Khafagy ; Ibrahim M. Salem

ABSTRACT:

The global antibiotic resistance crisis demands innovative strategies targeting bacterial virulence rather than survival. Quorum sensing (QS), a key regulator of virulence and biofilm formation, offers a promising avenue to mitigate resistance by disarming pathogens without bactericidal pressure. This study investigates the repurposing of nitroimidazoles as anti‐QS and anti‐virulence agents at subminimum inhibitory concentrations (sub‐MICs). In Silico analyses, including molecular docking and molecular dynamics (MD) simulations, were performed to investigate ligand‐receptor interactions with structurally distinct Lux‐type QS receptors and assess binding stability and conformational dynamics over time. In Vitro assays evaluated the effects of representative nitroimidazoles, metronidazole (MET) and secnidazole (SEC), on QS‐controlled phenotypes, including violacein production in Chromobacterium violaceum and biofilm formation and protease activity in Pseudomonas aeruginosa , Acinetobacter baumannii , Salmonella enterica , and Proteus mirabilis . In Vivo efficacy was assessed using a murine infection model and HeLa cell invasion assays. Molecular docking revealed high‐affinity binding to QS receptors, corroborating their mechanistic interference. Sub‐MIC MET/SEC significantly suppressed violacein synthesis, biofilm biomass, and protease secretion in Gram‐negative pathogens. Both compounds reduced bacterial invasiveness in HeLa cells and In Vivo protected mice from lethal P. aeruginosa infections. Crucially, nitroimidazoles attenuated virulence without affecting bacterial viability, preserving microbial ecology. These findings position nitroimidazoles as dual‐function agents; antimicrobial at bactericidal doses and anti‐virulence at sub‐MICs. Their validated efficacy across In Silico, In Vitro, and In Vivo models underscores their potential as adjunctive therapies, bridging the gap between drug repurposing and next‐generation anti‐infective development.

News (Medical) associated with Nimorazole

22 Jan 2026

·www.afyxtx.com

AFYX Therapeutics enters strategic partnership with Adcock Ingram Critical Care

PRESS RELEASE AFYX Therapeutics enters strategic partnership with Adcock Ingram Critical Care for distribution in South Africa and Sub-Saharan Africa. Copenhagen, Denmark – January 22, 2026. AFYX Therapeutics has entered a strategic distribution partnership with Adcock Ingram Critical Care (AICC), a leading provider of hospital and specialty medicines in South Africa. The partnership includes exclusive distribution of AFYX’s innovative products in South Africa and 10 additional countries in the Sub-Saharan region. Scope and Products Gefena® (misoprostol 25 µg oral tablet): Gefena® is developed for labor induction and represents a significant improvement over existing treatments. The product is administered as a 25-µg oral tablet, which is the precise dose recommended by HO as the first choice for induction of labor. Gefena® has demonstrated a lower risk of complications such as cesarean section and low Apgar scores compared to competing products. It requires no refrigeration, is easy to administer, and has successfully completed bioequivalence studies with positive results. Labor induction is necessary in up to 25–30% of all births in Europe and similarly high rates in Africa, highlighting the substantial unmet medical need. Market potential is considerable, and the product is under regulatory review in Europe. Nimorazole: Nimorazole is an innovative radiosensitizer and DNA repair inhibitor used as an adjunct to radiotherapy for patients with head and neck cancer. The product has shown significant improvement in local control and survival among patients with hypoxic tumors. Data from large clinical studies, including DAHANCA 5 and DAHANCA 29, demonstrate that the use of Nimorazole in combination with standard radiotherapy can reduce the 3-year risk of relapse with almost 40% (from 33,8% relapse in the control group to 20,7% in the nimorazole group). The product has been used in Denmark and Norway for more than 10 years and is expected to gain broader regulatory approval in Europe and Africa within the next 2 years. Strategic Importance This partnership strengthens AFYX Therapeutics’ presence in the African markets and ensures access to advanced treatments for patients with significant unmet medical needs. Adcock Ingram Critical Care brings strong local expertise and a well-established distribution network, making them an ideal partner for AFYX in the region. Statement from Management Claus Møller-San Pedro, CEO of AFYX Therapeutics, states:“We are proud to enter this partnership with Adcock Ingram Critical Care. It marks an important step in our global expansion strategy and ensures that patients across Sub-Saharan Africa gain access to our innovative treatments.” About AFYX Therapeutics At AFYX, “Reversed Innovation” is our core value. As a leader in the biopharmaceutical industry, we focus on repurposing existing products or technologies to address new or previously overlooked medical conditions. Visit www.afyxtx.com. …. For more information, please contact Dr. Claus Møller-San Pedro at cm@afyxtx.com. CLAUS MØLLER-SAN PEDROCEO & Founder DOWNLOAD AS PDF

Clinical ResultDrug Approval

05 May 2025

·www.afyxtx.com

Breakthrough in Hypoxic Modification for Head and Neck Cancer Patients receiving Chemoradiation Treatment

PRESS RELEASE Breakthrough in Hypoxic Modification for Head and Neck Cancer Patients receiving Chemoradiation Treatment Presented at ESTRO 2025 FOR IMMEDIATE RELEASE – Date: May 5th, 2025 Clinical Study Demonstrates Improved Locoregional Control with Nimorazole in Advanced Head and Neck Cancer A recent multicenter randomized trial presented at the European Society for Radiotherapy and Oncology (ESTRO) 2025 conference has revealed significantly positive results for the use of AFYX Therapeutics A/S patented proprietary nimorazole (NIM) product as a hypoxic radiosensitizer in the treatment of locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). The study, led by Vincent Gregoire, Jens Overgaard and colleagues from various European institutions, aimed to confirm the benefits of NIM in combination with accelerated chemo-radiotherapy. Key Findings: Study Design: The trial included 194 patients with stage III-IV laryngeal, hypopharyngeal, or HPV-negative oropharyngeal SCC, randomized to receive either NIM or placebo alongside chemo-radiotherapy. Treatment Regimen: Accelerated radiotherapy was delivered using IMRT (70 Gy in 6 weeks), with cisplatin administered either weekly (40 mg/m²) or every three weeks (100 mg/m²). NIM or placebo was given orally at a daily dose of 1.2 mg/m² prior to each fraction of radiation. Primary Endpoint: The primary endpoint was the 3-year locoregional failure rate. Results showed a significant (p-value 0.04) reduction in locoregional failure for patients receiving NIM (18%) compared to placebo (30%), with a hazard ratio (HR) of 0.63. Secondary Endpoints: Disease-specific survival (DSS) and overall survival (OS) did not show significant differences between the NIM and placebo groups. Safety and Compliance: Treatment compliance was similar across both groups, with no significant differences in treatment-related morbidity except for higher nephrotoxicity in the 3-weekly cisplatin regimen. Conclusion: Despite the reduced patient number due to premature trial closure, the study demonstrated that nimorazole improves locoregional control in advanced HPV-negative HNSCC. This underlines that hypoxic modification is still active in concomitant chemo-radiotherapy of squamous cell carcinoma. At AFYX, “Reversed Innovation” is our core value. As a leader in the biopharmaceutical industry, we focus on repurposing existing products or technologies to address new or previously overlooked medical conditions. Visit www.afyxtx.com. …. For more information, please contact Dr. Claus Møller-San Pedro at cm@afyxtx.com or phone +4540539894 CLAUS MØLLER-SAN PEDROCEO & Founder

Clinical ResultRadiation Therapy

05 May 2025

·afyxtx.com

Breakthrough in Hypoxic Modification for Head and Neck Cancer Patients

Vienna, Austria – May 5, 2025 Breakthrough in Hypoxic Modification for Head and Neck Cancer Patients receiving Chemoradiation Treatment Presented at ESTRO 2025. Clinical Study Demonstrates Improved Locoregional Control with Nimorazole in Advanced Head and Neck Cancer. A recent multicenter randomized trial presented at the European Society for Radiotherapy and Oncology (ESTRO) 2025 conference has revealed significantly positive results for the use of AFYX Therapeutics A/S patented proprietary nimorazole (NIM) product as a hypoxic radiosensitizer in the treatment of locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). The study, led by Vincent Gregoire, Jens Overgaard and colleagues from various European institutions, aimed to confirm the benefits of NIM in combination with accelerated chemo-radiotherapy. Key Findings: • Study Design: The trial included 194 patients with stage III-IV laryngeal, hypopharyngeal, or HPV-negative oropharyngeal SCC, randomized to receive either NIM or placebo alongside chemo-radiotherapy. • Treatment Regimen: Accelerated radiotherapy was delivered using IMRT (70 Gy in 6 weeks), with cisplatin administered either weekly (40 mg/m²) or every three weeks (100 mg/m²). NIM or placebo was given orally at a daily dose of 1.2 mg/m² prior to each fraction of radiation. • Primary Endpoint: The primary endpoint was the 3-year locoregional failure rate. Results showed a significant (p-value 0.04) reduction in locoregional failure for patients receiving NIM (18%) compared to placebo (30%), with a hazard ratio (HR) of 0.63. • Secondary Endpoints: Disease-specific survival (DSS) and overall survival (OS) did not show significant differences between the NIM and placebo groups. • Safety and Compliance: Treatment compliance was similar across both groups, with no significant differences in treatment-related morbidity except for higher nephrotoxicity in the 3-weekly cisplatin regimen. Conclusion: Despite the reduced patient number due to premature trial closure, the study demonstrated that nimorazole improves locoregional control in advanced HPV-negative HNSCC. This underlines that hypoxic modification is still active in concomitant chemo-radiotherapy of squamous cell carcinoma. At AFYX, “Reversed Innovation” is our core value. As a leader in the biopharmaceutical industry, we focus on repurposing existing products or technologies to address new or previously overlooked medical conditions. For more information, please contact Dr. Claus Møller-San Pedro at cm@afyxtx.com or phone +4540539894 CLAUS MØLLER-SAN PEDRO CEO & Founder DOWNLOAD AS PDF

Clinical ResultRadiation Therapy

100 Deals associated with Nimorazole

External Link

KEGG	Wiki	ATC	Drug Bank
D07352	Nimorazole	P01AB06	DB12172

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Amebiasis	-	-	-
Giardiasis	-	-	-
Gingivitis	-	-	-
Trichomonas Infections	-	-	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	United Kingdom	The Christie Pathology Partnership LLP	11 Sep 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01950689 (NIMRAD, Pubmed \| Int J Radiat Oncol Biol Phys)	Phase 3	Head and Neck Neoplasms	338	Nimorazole + Nimorazole (HNSCC)	wwbejqzjmw(fzsrpfxztf) = Nimorazole + IMRT caused more acute nausea compared with placebo + IMRT (Common Terminology Criteria for Adverse Events version 4.0 G1+2: 56.6% vs 42.4%, G3: 10.1% vs 5.3%, respectively; P <.05) guohbmdedx (dyxwesnrgt )	Negative	01 Jul 2024
NCT01950689 (NIMRAD, ASCO2023) Manual	Phase 3	Head and Neck Neoplasms	139	Nimorazole+RT (hypoxic group)	kpmbpaxvje(vpzotiomuk): adjusted HR = 0.72 (95% CI, 0.36 - 1.44), P-Value = 0.35 View more	Negative	31 May 2023
NCT01950689 (NIMRAD, ASCO2023) Manual	Phase 3	Head and Neck Neoplasms	139	Placebo+RT (hypoxic group)		Negative	31 May 2023

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