Lorlatinib clinical trials
Lorlatinib is named as an intervention in 21 current clinical trials in our China, USA, France, Netherlands, Spain, Canada, Japan, India, Germany, Italy, Belgium, Mexico, Taiwan, Singapore, Australia, UK, Poland, Czechia, Turkey, South Korea, Norway and Israel registers. 11 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Pfizer (4). The most-studied condition is ALK Positive Non-small Cell Lung Cancer. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Lorlatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Lorlatinib was the US, on 2 Nov 2018. It is approved in 3 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.
Lorlatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lorlatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 4 Oct 2038 (US 11299500).
- Latest patent on the drug substance itself: 4 Oct 2038 (US 11299500).
- Exclusivity ODE-349: Orphan drug exclusivity: treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphom…, until 3 Mar 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 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.
What health systems spend on Lorlatinib
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 Lorlatinib works
All drug targets →- ALK tyrosine kinase receptor inhibitor InhibitorTarget: ALK ALK receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- EML4-ALK inhibitor InhibitorTarget: EML4-ALK✓ In ChEMBL and the Guide to Pharmacology
- Inhibits ROS1 Primary targetTarget: ROS1 ROS proto-oncogene 1, receptor tyrosine kinaseGuide to Pharmacology only
- GanglioneuroblastomaPhase 3
- Lung adenocarcinomaPhase 3
- NeuroblastomaPhase 3
- MetastasisPhase 2
- Non-Hodgkin lymphomaPhase 2
- Plasma cell myelomaPhase 2
- Thyroid gland carcinomaPhase 2
- Lung cancerPhase 1/2
- Hematopoietic and lymphoid cell neoplasmPhase 1
- Diffuse intrinsic pontine gliomaEarly phase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3286830, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7476, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Lorlatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Lorlatinib. 2 are current, and 2 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Lorlatinib for ALK-positive advanced non-small-cell lung cancer that has not been treated with an ALK inhibitor NICE TA1103 | Recommended | 21 Oct 2025 | Current |
| Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer NICE TA628 | Recommended | 13 May 2020 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Lorlatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LorviquaEMA product information: package leaflet and summary of product characteristics in every EU language.
- 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.
Reference identifiers for Lorlatinib
- ATC code
- L01XE44
- ChEMBL
- CHEMBL3286830
- DrugBank
- DB12130
- PubChem CID
- 71731823
- CAS number
- 1454846-35-5
- FDA UNII
- OSP71S83EU
- Wikidata
- Q27285820
- Wikipedia
- Lorlatinib
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
Trials by phase
Clinical trials of Lorlatinib
21 trialsRegisters 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.
Lorlatinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Lorlatinib. 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 |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
Lorlatinib 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)
2 single-substance products containing Lorlatinib on the HPRA medicines list.
- Lorviqua 100 mg film-coated tabletPfizer Europe MA EEIG · EU/1/19/1355/002
- Lorviqua 25 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/19/1355/001
Supply shortages
- Lorlatinib TabletUS (FDA) · Resolved · updated 15 Jun 2026
Conditions studied with Lorlatinib
36 conditionsAll 36 conditions
| Condition (as registered) | Trials |
|---|---|
| ALK Positive Non-small Cell Lung Cancer | 4 |
| Carcinoma, Non-Small-Cell Lung | 2 |
| NSCLC | 2 |
| ALK+ Non-Small-Cell Lung Carcinoma | 2 |
| Non Small Cell Lung Cancer | 2 |
| ALK Gene Mutation | 2 |
| Non Small Cell Lung Cancer Metastatic | 2 |
| Non-Small-Cell Lung | 1 |
| ALK-positive Advanced NSCLC | 1 |
| ALK-positive Non-small-cell Lung Cancer | 1 |
| ALK-positive NSCLC | 1 |
| Non-Small-Cell Lung Cancer | 1 |
| ALK Positive | 1 |
| Non-small Cell Lung Cancer | 1 |
| Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer | 1 |
| Non-Small Cell Lung Cancer | 1 |
| Hyperlipidemia | 1 |
| Brain Metastases | 1 |
| Leptomeningeal Metastasis | 1 |
| Stage III NSCLC | 1 |
| Surgery | 1 |
| ALK-positive Non-small Cell Lung Cancer | 1 |
| Real World Study | 1 |
| EGFR Gene Mutation | 1 |
| ROS1 Gene Mutation | 1 |
| High Grade Glioma | 1 |
| Diffuse Intrinsic Pontine Glioma | 1 |
| Anaplastic Astrocytoma | 1 |
| Infant Type Hemispheric Glioma | 1 |
| Cancer | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Ganglioneuroblastoma | 1 |
| Ganglioneuroblastoma, Nodular | 1 |
| Neuroblastoma | 1 |
Sponsors
lead sponsor per trialBy country register
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 Lorlatinib trials
How many clinical trials are testing Lorlatinib?
21 current trials in our China, USA, France, Netherlands, Spain, Canada, Japan, India, Germany, Italy, Belgium, Mexico, Taiwan, Singapore, Australia, UK, Poland, Czechia, Turkey, South Korea, Norway and Israel registers name Lorlatinib (also registered as PF-06463922) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Lorlatinib trials recruiting patients?
Yes. 11 of the 21 trials are recruiting: 4 with sites in China, 2 with sites in USA, 1 with sites in France, 2 with sites in Netherlands, 2 with sites in Canada, 1 with sites in Japan, 1 with sites in Germany, 1 with sites in Italy, 1 with sites in Mexico, 1 with sites in Australia and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lorlatinib clinical trials?
Pfizer (4), Guangdong Association of Clinical Trials (3), Hunan Province Tumor Hospital (2) and Chugai Pharmaceutical (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Lorlatinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Lorlatinib, for example Lorviqua 100 mg film-coated tablet (Pfizer Europe MA EEIG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Lorlatinib shortage?
The registers we track list 1 entry for Lorlatinib: US FDA: resolved. 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 Lorlatinib 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 Lorlatinib 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 Lorlatinib (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.