Cetirizine Hydrochloride is named as an intervention in 2 current clinical trials in our China register. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Shandong New Time Pharmaceutical Co., LTD (1). The most-studied condition is Acute Urticaria. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Of the three regulators tracked here, the first to approve Cetirizine Hydrochloride was the US, on 8 Dec 1995. 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.
Protections still running for marketed products containing Cetirizine Hydrochloride, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria
NCT06819774 · ClinicalTrials.gov ↗ · Acute Urticaria
|
Phase 3 | Recruiting | Shandong New Time Pharmaceutical Co., LTD | China |
|
The Treatment of Moderate to Severe Allergic Rhinitis With Electroacupuncture Combined With Microneedle Knife
NCT06890260 · ClinicalTrials.gov ↗ · Allergic Rhinitis (Disorder), Electroacupuncture, Microneedle Knife
|
Not applicable | Recruiting | Pengfei Qiu | 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.
Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Cetirizine Hydrochloride. 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 |
|---|---|---|---|---|
|
The HIt HArd and hiT early in multiple sclerosis trial – HiHat trial
2024-519700-28-01 · CTIS ↗ · Nervous System Diseases
|
Phase 2 | Ongoing | Region Uppsala | Sweden |
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
5 single-substance products containing Cetirizine Hydrochloride on the HPRA medicines list.
No entry for Cetirizine Hydrochloride in the EMA, FDA or German BfArM shortage lists we track.
| Lead sponsor | Trials |
|---|---|
| Shandong New Time Pharmaceutical Co., LTD | 1 |
| Pengfei Qiu | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 2 | 2 |
| 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.
2 current trials in our China register name Cetirizine Hydrochloride as a drug or biological intervention, as of the registry sync on 28 September 2026. Completed and withdrawn studies are not counted.
Yes. 2 of the 2 trials are recruiting: 2 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Shandong New Time Pharmaceutical Co., LTD (1) and Pengfei Qiu (1). The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 5 single-substance products containing Cetirizine Hydrochloride, for example Cetrine 10 mg Film-coated Tablets (Rowex Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Cetirizine Hydrochloride has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Cetirizine Hydrochloride works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Cetirizine Hydrochloride 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 Cetirizine Hydrochloride (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 28 Sep 2026.