Cefaclor clinical trials
Cefaclor is named as an intervention in 2 current clinical trials in our China and Spain registers. 2 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Children's Hospital of Fudan University (1). The most-studied condition is Biliary Atresia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Cefaclor is approved
All regulators →Of the three regulators tracked here, the first to approve Cefaclor was the US, on 4 Apr 1979. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Cefaclor
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Cefaclor works
All drug targets →- Bacterial penicillin-binding protein inhibitor InhibitorChEMBL only
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201018, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10897, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Cefaclor
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Cefaclor
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
NCT05398679 · ClinicalTrials.gov ↗ · Endocarditis Infective
|
Phase 4 | Recruiting | Fundacion Clinic per a la Recerca Biomédica | Spain |
|
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
NCT05925309 · ClinicalTrials.gov ↗ · Biliary Atresia, Cholangitis, Anti-Bacterial Agents
|
Not applicable | Recruiting | Children's Hospital of Fudan University | China |
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.
Cefaclor in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Cefaclor. 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.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci
2026-526149-91-00 · Bacterial Infections and Mycoses
|
Phase 3 | Authorised | Friedrich-Schiller-Universitaet Jena | Germany |
Cefaclor across our data
Ireland · EU · USThe 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)
4 single-substance products containing Cefaclor on the HPRA medicines list.
- Distaclor 125 mg/5 ml Granules for Oral SuspensionFlynn Pharma Limited · PA1226/001/002 · Marketed
- Distaclor 250 mg/5 ml Granules for Oral SuspensionFlynn Pharma Limited · PA1226/001/003 · Marketed
- Distaclor LA 375 mg prolonged-release tabletsFlynn Pharma Limited · PA1226/001/004 · Marketed
- Distaclor LA Forte 500 mg prolonged-release tabletsFlynn Pharma Limited · PA1226/001/005 · Marketed
Supply shortages
- CEFACLOR BASICS 250 mg TSGermany (BfArM) · Production problem · 1 Dec 2025 to 30 Nov 2026
- CEFACLOR BASICS 250 mg TSGermany (BfArM) · Production problem · 1 Dec 2025 to 30 Nov 2026
- CEFACLOR BASICS 125 mg TSGermany (BfArM) · Production problem · 7 Apr 2026 to 30 Nov 2026
- Cefaclor 250 TS - 1 A PharmaGermany (BfArM) · Other reason · 14 Aug 2026 to 31 Dec 2026
- Cefaclor 125 TS - 1 A PharmaGermany (BfArM) · Other reason · 22 Sep 2026 to 31 Dec 2026
Conditions studied with Cefaclor
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Children's Hospital of Fudan University | 1 |
| Fundacion Clinic per a la Recerca Biomédica | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 1 | 1 |
| Clinical trials in Spain | 1 | 1 |
| EU register (CTIS) | 1 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Cefaclor trials
How many clinical trials are testing Cefaclor?
2 current trials in our China and Spain registers name Cefaclor as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Cefaclor trials recruiting patients?
Yes. 2 of the 2 trials are recruiting: 1 with sites in China and 1 with sites in Spain. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Cefaclor clinical trials?
Children's Hospital of Fudan University (1) and Fundacion Clinic per a la Recerca Biomédica (1). The number in brackets is how many trials each organisation leads.
Is Cefaclor licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Cefaclor, for example Distaclor 125 mg/5 ml Granules for Oral Suspension (Flynn Pharma Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Cefaclor shortage?
The registers we track list 5 entries for Cefaclor: 5 German notices. Shortages are product- and country-specific; check with a pharmacist.
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 Cefaclor works or whether it is effective, and it is not medical advice.
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 Cefaclor works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Cefaclor (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.