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Priya Life Science Compound trial record
Compound · clinical trials

Folinic acid clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 14 trials in our USA, Germany, Japan, France, Spain, South Korea, China, Italy, Belgium, Taiwan, Israel, Canada, Mexico, UK, Poland, Brazil, Australia, Sweden and Singapore registers that name Folinic acid as an intervention. Synced 9 Nov 2026
14Current trials
8Recruiting now
11Lead sponsors
19Country registers
At a glance

Folinic acid is named as an intervention in 14 current clinical trials in our USA, Germany, Japan, France, Spain, South Korea, China, Italy, Belgium, Taiwan, Israel, Canada, Mexico, UK, Poland, Brazil, Australia, Sweden and Singapore registers. 8 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Astellas Pharma Global Development, Inc (3). The most-studied condition is Autism Spectrum Disorder. The EU clinical trials register (CTIS) separately lists 5 authorised or ongoing trials, 1 with a site in Ireland.

How Folinic acid works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Down syndromePhase 3
  • Colon carcinomaPhase 3
  • Colorectal cancerPhase 3
  • Exocrine pancreatic carcinomaPhase 3
  • Gastric cancerPhase 3
  • Gastroesophageal junction adenocarcinomaPhase 3
  • Malignant colon neoplasmPhase 3
  • Metastatic colorectal cancerPhase 3
  • Pancreatic adenocarcinomaPhase 3
  • Psychotic disorderPhase 3
44 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1232801, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Folinic acid

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Folinic acid

ChEMBL
CHEMBL1232801
DrugBank
DB03256
PubChem CID
135484651
CAS number
73951-54-9
FDA UNII
VR9EYV4XBE
Wikidata
Q27094183

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting857%
  • Not yet open17%
  • Active, closed536%

Trials by phase

  • Phase 3643%
  • Phase 2643%
  • Phase 117%
  • Not applicable17%
01

Clinical trials of Folinic acid

14 trials
StudyPhaseStatusLead sponsorRegisters
Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver
NCT02885753 · ClinicalTrials.gov ↗ · Colorectal Neoplasms
Phase 3 Recruiting Federation Francophone de Cancerologie Digestive France, Belgium
Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature
NCT05314998 · ClinicalTrials.gov ↗ · Pancreatic Ductal Adenocarcinoma
Phase 3 Recruiting John Neoptolemos Germany, Sweden
The Sagittarius Trial
NCT06490536 · ClinicalTrials.gov ↗ · Colon Cancer Stage II, Colon Cancer Stage III
Phase 3 Recruiting IFOM ETS - The AIRC Institute of Molecular Oncology Germany, Spain, Italy
A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer
NCT07673887 · Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
Phase 3 Recruiting Astellas Pharma Global Development, Inc USA, China, Japan
Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
NCT06928584 · ClinicalTrials.gov ↗ · Locally Recurrent Rectal Cancer
Phase 2 Recruiting Fudan University China
Folinic Acid as a Treatment for Autism Spectrum Disorder in Children
NCT07630506 · ClinicalTrials.gov ↗ · Autism Spectrum Disorder
Phase 2 Recruiting KK Women's and Children's Hospital Singapore
A Placebo-controlled Trial of Folinic Acid in Children With ASD
NCT07642661 · ClinicalTrials.gov ↗ · Autism Spectrum Disorder
Phase 2 Recruiting Prof. Adi Aran Israel
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
NCT07283939 · ClinicalTrials.gov ↗ · Ampulla of Vater Carcinoma, Appendix Carcinoma, Carcinoma of Unknown Primary With Gastrointestinal Profile
Not applicable Recruiting Alliance for Clinical Trials in Oncology Mexico
Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer
NCT07150403 · ClinicalTrials.gov ↗ · Metastatic Colorectal Carcinoma (mCRC)
Phase 2 Not yet open Federation Francophone de Cancerologie Digestive France
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
NCT03504397 · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer
Phase 3 Active, closed Astellas Pharma Global Development, Inc UK, USA, China, Germany, France, Spain, Italy, Belgium, Poland, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel
Short RT Versus RCT,Followed by Chemo and Organ Preservation for Interm and High-risk Rectal Cancer Patients
NCT04246684 · ClinicalTrials.gov ↗ · Rectal Cancer Stage III
Phase 3 Active, closed Prof. Dr. med. Claus Rödel Germany
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
NCT03505320 · Pharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer
Phase 2 Active, closed Astellas Pharma Global Development, Inc USA, France, Italy, Japan, South Korea, Taiwan
Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
NCT06107413 · Unresectable Metastatic Colorectal Cancer
Phase 2 Active, closed AbbVie USA, Germany, Spain, Belgium, Japan, South Korea, Taiwan, Israel
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
NCT05464030 · Colorectal Cancer
Phase 1 Active, closed EMD Serono Research & Development Institute, Inc USA, Spain, Canada, Japan, South Korea

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Folinic acid in the EU trials register (CTIS)

5 trials · 1 in Ireland

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Folinic acid. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)
2025-521587-35-00 · Neoplasms
Phase 3 Ongoing Summit Therapeutics Inc Ireland + 8 more
COLIBRI-GI_Randomized phase 2 study of second-line chemotherapy comparing FOLFIRI + ivonescimab versus FOLFIRI + bevacizumab in Microsatellite Stable (MSS)/ proficient MisMatch Repair (pMMR) BRAF wild type (wt) advanced colorectal cancer (mCRC) without liver metastases
2025-524215-36-00 · Neoplasms
Phase 2 Authorised Unicancer France
PACHA-02_Postoperative hepatic arterial chemotherapy after resection of colorectal liver metastases in patients at high risk of recurrence
2025-523913-27-00 · CTIS ↗ · Neoplasms
Phase 3 Authorised Unicancer France
NACRE 2_Randomized phase III study evaluating two treatment strategies for locally advanced rectal cancer in patients ≥75 years old
2025-521619-37-00 · CTIS ↗ · Neoplasms
Phase 3 Authorised Unicancer France
Randomized study to compare first-line treatment with either continuous or intermittent cetuximab plus FOLFIRI in patients with RAS/BRAF-wild-type metastatic colorectal cancer (mCRC): AIO-KRK-0524 / FIRE-11
2025-522377-12-00 · CTIS ↗ · Neoplasms
Phase 3 Authorised Charite Universitaetsmedizin Berlin KöR Germany
03

Folinic acid across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

2 single-substance products containing Folinic acid on the HPRA medicines list.

All 2 Irish products →

Supply shortages

No entry for Folinic acid in the EMA, FDA or German BfArM shortage lists we track.

04

Conditions studied with Folinic acid

24 conditions
Autism Spectrum Disorder2Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer1Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer1Metastatic Gastric Adenocarcinoma or Cancer1Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma1Unresectable Metastatic Colorectal Cancer1Gastric Adenocarcinoma1Gastroesophageal Junction (GEJ) Adenocarcinoma1Colorectal Cancer1Pharmacokinetics of Zolbetuximab1Gastric Cancer1Gastro-esophageal Junction (GEJ) Cancer1
All 24 conditions
Condition (as registered)Trials
Autism Spectrum Disorder2
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer1
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer1
Metastatic Gastric Adenocarcinoma or Cancer1
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma1
Unresectable Metastatic Colorectal Cancer1
Gastric Adenocarcinoma1
Gastroesophageal Junction (GEJ) Adenocarcinoma1
Colorectal Cancer1
Pharmacokinetics of Zolbetuximab1
Gastric Cancer1
Gastro-esophageal Junction (GEJ) Cancer1
Pharmacokinetics of Oxaliplatin1
Locally Recurrent Rectal Cancer1
Colon Cancer Stage II1
Colon Cancer Stage III1
Pancreatic Ductal Adenocarcinoma1
Rectal Cancer Stage III1
Metastatic Colorectal Carcinoma (mCRC)1
Colorectal Neoplasms1
Ampulla of Vater Carcinoma1
Appendix Carcinoma1
Carcinoma of Unknown Primary With Gastrointestinal Profile1
Colon Carcinoma1
07

Related compounds

08

Questions about Folinic acid trials

How many clinical trials are testing Folinic acid?

14 current trials in our USA, Germany, Japan, France, Spain, South Korea, China, Italy, Belgium, Taiwan, Israel, Canada, Mexico, UK, Poland, Brazil, Australia, Sweden and Singapore registers name Folinic acid as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Folinic acid trials recruiting patients?

Yes. 8 of the 14 trials are recruiting: 1 with sites in USA, 2 with sites in Germany, 1 with sites in Japan, 1 with sites in France, 1 with sites in Spain, 2 with sites in China, 1 with sites in Italy, 1 with sites in Belgium, 1 with sites in Israel, 1 with sites in Mexico, 1 with sites in Sweden and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Folinic acid clinical trials?

Astellas Pharma Global Development, Inc (3), Federation Francophone de Cancerologie Digestive (2), AbbVie (1) and EMD Serono Research & Development Institute, Inc (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Are there Folinic acid clinical trials in Ireland?

Yes. 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Is Folinic acid licensed in Ireland?

Yes. The HPRA medicines list includes 2 single-substance products containing Folinic acid, for example Folinic acid (as calcium folinate) 10 mg/ml solution for injection or infusion (Fresenius Kabi Deutschland GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Folinic acid shortage?

Not in the lists we track: Folinic acid has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Folinic acid works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Folinic acid works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Folinic acid (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.