Isofol Medical AB (5IU) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Arfolitixorin (Arfox + Bevacizumab) | Metastatic Colorectal Cancer (Mcrc) | phase1AndPhase2 | Recruiting | A Clinical Study of Arfolitixorin in Patients With mCRC | Mar 25, 2025 | ― |
| Leucovorin, Arfolitixorin | Colo-Rectal Cancer | Phase III | Completed | A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer | Nov 19, 2018 | ― |
| Modufolin (Arfolitixorin) | Phase I Study In Healthy Volunteers To Evaluate Ecg Effect | Phase I | Completed | Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers | Jun 22, 2017 | ― |
| Bevacizumab, Fluorouracil, Oxaliplatin, Irinotecan, Modufolin (Arfolitixorin) | Colorectal Neoplasm | phase1AndPhase2 | Completed | Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer | Sep 17, 2014 | ― |
| Calcium Folinate, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin) | Osteosarcoma | phase1AndPhase2 | Completed | Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX. | Nov 05, 2013 | ― |
| 6R-Mthf (Arfolitixorin) 200 Mg/M2, Levoleucovorin 200 Mg/M2, 6R-Mthf (Arfolitixorin) 60 Mg/M2, Levoleucovorin 60 Mg/M2 | Colonic Neoplasms | phase1AndPhase2 | Completed | PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer | Sep 05, 2012 | ― |
| Pemetrexed, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin) | Rectal Cancer | phase1AndPhase2 | Completed | An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer | May 25, 2011 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Arfolitixorin (Arfox + Bevacizumab) | phase1AndPhase2 | Metastatic Colorectal Cancer (Mcrc) | Recruiting | A Clinical Study of Arfolitixorin in Patients With mCRC | Mar 25, 2025 | ― |
| Leucovorin, Arfolitixorin | Phase III | Colo-Rectal Cancer | Completed | A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer | Nov 19, 2018 | ― |
| Modufolin (Arfolitixorin) | Phase I | Phase I Study In Healthy Volunteers To Evaluate Ecg Effect | Completed | Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers | Jun 22, 2017 | ― |
| Bevacizumab, Fluorouracil, Oxaliplatin, Irinotecan, Modufolin (Arfolitixorin) | phase1AndPhase2 | Colorectal Neoplasm | Completed | Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer | Sep 17, 2014 | ― |
| Calcium Folinate, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin) | phase1AndPhase2 | Osteosarcoma | Completed | Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX. | Nov 05, 2013 | ― |
| 6R-Mthf (Arfolitixorin) 200 Mg/M2, Levoleucovorin 200 Mg/M2, 6R-Mthf (Arfolitixorin) 60 Mg/M2, Levoleucovorin 60 Mg/M2 | phase1AndPhase2 | Colonic Neoplasms | Completed | PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer | Sep 05, 2012 | ― |
| Pemetrexed, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin) | phase1AndPhase2 | Rectal Cancer | Completed | An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer | May 25, 2011 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Isofol Medical AB (DE:5IU) have in its pipeline
Isofol Medical AB DE:5IU is currently developing the following drugs: Arfolitixorin (Arfox + Bevacizumab), Leucovorin, Arfolitixorin, Modufolin (Arfolitixorin), Bevacizumab, Fluorouracil, Oxaliplatin, Irinotecan, Modufolin (Arfolitixorin), Calcium Folinate, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin), 6R-Mthf (Arfolitixorin) 200 Mg/M2, Levoleucovorin 200 Mg/M2, 6R-Mthf (Arfolitixorin) 60 Mg/M2, Levoleucovorin 60 Mg/M2, Pemetrexed, [6R] 5,10-Methylenetetrahydrofolate (Arfolitixorin). These drug candidates are in various stages of clinical development as the company works toward FDA approval.