Lenacapavir clinical trials
Lenacapavir is named as an intervention in 19 current clinical trials in our USA, Canada, Australia, France, Spain, Italy, Japan, UK, Germany, Taiwan, South Korea, Mexico, Netherlands and Brazil registers. 8 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Gilead Sciences (18). The most-studied condition is HIV-1-infection. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Lenacapavir is approved
All regulators →Of the three regulators tracked here, the first to approve Lenacapavir was the EU, on 17 Aug 2022. 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.
Lenacapavir patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lenacapavir, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 28 Aug 2041 (US 11944611).
- Latest patent on the drug substance itself: 16 Aug 2038 (US 11267799).
- Exclusivity I-999: New indication: indicated for oral loading as a component of the initiation regimen for bictegravir and lenacapavir fixed-dose combination …, until 27 Aug 2029.
- Exclusivity NP: New product, until 18 Jun 2028.
- Exclusivity NCE: New chemical entity, until 22 Dec 2027.
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 Lenacapavir
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 Lenacapavir works
All drug targets →- Structural capsid protein inhibitor InhibitorChEMBL only
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594438, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11446, 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 Lenacapavir
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.
- EU
- 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 Lenacapavir
19 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.
Lenacapavir in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Lenacapavir. 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.
Lenacapavir 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 Lenacapavir on the HPRA medicines list.
- Sunlenca 300 mg film-coated tabletsGilead Sciences Ireland UC · EU/1/22/1671/01
- Sunlenca 464 mg solution for injectionGilead Sciences Ireland UC · EU/1/22/1671/02
- Yeytuo 300 mg film-coated tabletsGilead Sciences Ireland Unlimited Company · EU/1/25/1976/001
- Yeytuo 464 mg solution for injectionGilead Sciences Ireland Unlimited Company · EU/1/25/1976/002
Supply shortages
No entry for Lenacapavir in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Lenacapavir
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Gilead Sciences | 18 |
| Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | 1 |
By 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 Lenacapavir trials
How many clinical trials are testing Lenacapavir?
19 current trials in our USA, Canada, Australia, France, Spain, Italy, Japan, UK, Germany, Taiwan, South Korea, Mexico, Netherlands and Brazil registers name Lenacapavir (also registered as GS-6207) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Lenacapavir trials recruiting patients?
Yes. 8 of the 19 trials are recruiting: 7 with sites in USA, 2 with sites in Canada, 2 with sites in Australia, 1 with sites in France and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lenacapavir clinical trials?
Gilead Sciences (18) and Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida (1). The number in brackets is how many trials each organisation leads.
Is Lenacapavir licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Lenacapavir, for example Sunlenca 300 mg film-coated tablets (Gilead Sciences Ireland UC). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Lenacapavir shortage?
Not in the lists we track: Lenacapavir 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 Lenacapavir 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 Lenacapavir 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 Lenacapavir (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.