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Last update 10 Apr 2026
Nimorazole
Last update 10 Apr 2026
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Nimoral, Nimorazole (INN), K-1900 + [3] |
Target- |
Action inhibitors |
Mechanism DNA synthesis inhibitors |
Active Indication |
Inactive Indication |
Originator Organization- |
Active Organization- |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date- |
RegulationOrphan Drug (European Union) |
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Structure/Sequence
Molecular FormulaC9H14N4O3 |
InChIKeyMDJFHRLTPRPZLY-UHFFFAOYSA-N |
CAS Registry6506-37-2 |
Related
7
Clinical Trials associated with NimorazoleCTRI/2019/02/017477
A Phase II trial of Nimorazole with chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone
Start Date15 Mar 2019 |
Sponsor / Collaborator- |
NCT02661152
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.
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 |
CTRI/2017/09/009921
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 |
100 Clinical Results associated with Nimorazole
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100 Translational Medicine associated with Nimorazole
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100 Patents (Medical) associated with Nimorazole
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218
Literatures (Medical) associated with Nimorazole01 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 ; Grégoire, Vincent ; Alyamani, Najlaa ; 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 Jul 2025·RADIOTHERAPY AND ONCOLOGY
DAHANCA19: A randomized phase III study of primary curative (chemo)-radiotherapy and the EGFR-inhibitor zalutumumab for squamous cell carcinoma of the head and neck
Article
Author: Johansen, Jørgen ; Maare, Christian ; Overgaard, Jens ; Bratland, Åse ; Andersen, Maria ; Kristensen, Claus Andrup ; Eriksen, Jesper Grau ; Primdahl, Hanne ; Alsner, Jan
BACKGROUND AND PURPOSE:
Antibodies against the Epidermal Growth Factor receptor is suggested to decrease tumour failure and increase survival rates of patients (pts) with Head and Neck Squamous Cell Carcinomas (HNSCC) when combined with radiotherapy. This study aimed to evaluate if concurrent treatment with the EGFR inhibitor zalutumumab during (chemo-)radiotherapy improved outcome in pts with HNSCC.
MATERIALS AND METHODS:
Overall, 608 eligible pts with biopsy-verified HNSCC of the oral cavity, pharynx and larynx were accrued November 2007 to June 2012. Pts were randomized to a control-arm of primary accelerated radiotherapy predominantly 66-68 Gy, 2 Gy/fraction, 6fx/week and concomitant daily hypoxic radiosensitisation with nimorazole. St. III-IV carcinomas received weekly cisplatin 40 mg/m2 in addition to nimorazole. The zalutumumab-arm was identical to the control-arm plus zalutumumab 8 mg/kg. First dose was given the week before start of treatment and continued weekly during radiotherapy. Analyses were performed as intention-to-treat. Primary endpoint was loco-regional failure. Secondary endpoints were disease-specific survival and overall survival.
RESULTS:
In total, 307 pts were in the control-arm and 301 in the zalutumumab-arm. Median follow-up was 59 months. Patient and tumour parameters were well balanced. The 5-year loco-regional failure rate was 24 % in the zalutumumab-arm and 18 % in the control-arm; Hazard Ratio (HR) 1.16 (95 % CI 0.84-1.59); disease-specific survival; HR 1.04 (95 % CI 0.73-1.50) and overall survival; HR 1.21, (0.91-1.61). Effect of zalutumumab was not influenced by HPV/p16 status.
CONCLUSION:
Addition of concomitant zalutumumab to primary (chemo-)radiotherapy and concomitant nimorazole for HNSCC did not increase loco-regional control nor disease-specific or overall survival.
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: Aldawsari, Mohammed F. ; Salem, Ibrahim M. ; Lila, Amr Selim Abu ; Ibrahim, Tarek S. ; Almutairy, Bjad K. ; Hegazy, Wael A. H. ; Saqr, Ahmed Al ; Khafagy, El‐Sayed
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.
5
News (Medical) associated with Nimorazole22 Jan 2026
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
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Clinical ResultDrug Approval
05 May 2025
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
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
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Clinical ResultRadiation Therapy
100 Deals associated with Nimorazole
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D07352 | Nimorazole |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Amebiasis | - | - | - |
| Giardiasis | - | - | - |
| Gingivitis | - | - | - |
| Trichomonas Infections | - | - | - |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Phase 3 | United Kingdom | 11 Sep 2014 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 3 | 139 | Nimorazole+RT (hypoxic group) | nzlpbwodje(idteoobfrp): adjusted HR = 0.72 (95% CI, 0.36 - 1.44), P-Value = 0.35 View more | Negative | 31 May 2023 | ||
Placebo+RT (hypoxic group) |
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