Rentosertib UK
Investigational medicineRentosertib is an investigational medicine. It is not licensed in the UK or anywhere else, and it is not available to UK patients. A Phase III trial began in China in September 2026. More about availability in the UK.

The UK

Rentosertib and the UK

Rentosertib has never been tested at a UK site, and there is no MHRA, NICE or SMC activity. What the real UK connections are.

Rentosertib is an investigational medicine for idiopathic pulmonary fibrosis (IPF). It has never been tested at a trial site in the UK, or anywhere in Europe.

The plain summary

  • No UK or European trial site, ever. The first-in-human microdose study was in Australia, the Phase 1 studies were in New Zealand and China, the Phase 2a was in China, a second Phase 2a was registered in the United States, and the Phase 3 that began dosing in September 2026 is running at 47 centres in China only.
  • Nothing at the MHRA. There is no marketing authorisation application, no UK clinical trial authorisation, and no place in any UK early access scheme.
  • Nothing at NICE or the Scottish Medicines Consortium. Neither body has the medicine in its work programme, because neither can look at a medicine that has no licence.
  • No UK charity has mentioned it. A search of all 231 news articles published by Action for Pulmonary Fibrosis found no mention of rentosertib, of Insilico Medicine, or of TNIK, the protein the medicine acts on. Asthma + Lung UK has nothing either.

The two UK connections

Two UK organisations have done paid technical work on the trial data. Neither means the medicine has been tested in UK people, or looked at by a UK regulator.

Qureight, Cambridge. In July 2025 this imaging analytics company reported a deep-learning analysis of the chest CT scans from the Phase 2a trial. It said the scans showed no imbalance in disease severity between groups at the start, and that the Chinese group of participants looked representative of IPF elsewhere. The company’s own announcement page no longer works, and no involvement in the Phase 3 has been documented.

Fortrea Clinical Pharmacology Services, Leeds. This contract research organisation processed data from the Phase 2a trial. That is the only other UK involvement found anywhere in the programme.

Why the UK context matters now

The UK changed its clinical trial rules on 28 April 2026, with reforms intended to make the country a faster and more attractive place to run studies. Rentosertib’s sponsor has not used them.

On 9 June 2026 the MHRA launched an AI sandbox for medicines, a scheme for working out how regulators should assess products developed with artificial intelligence. Five projects were named. Rentosertib is not one of them. (A separate MHRA scheme called AI Airlock is sometimes confused with it, but that one covers medical devices, not medicines.)

The gate any new IPF medicine faces

Nerandomilast is the live example. The MHRA licensed it on 8 July 2026, the first approval in Europe, and the first new IPF medicine licensed in the UK for more than a decade. Six weeks later, on 19 August 2026, NICE published draft guidance saying it should not be used in the NHS in England, largely on cost-effectiveness grounds. A second committee meeting was held on 12 November 2026 and final guidance is expected on 20 January 2027.

A licence and NHS funding are two separate hurdles, and a medicine can clear the first and fail the second. Rentosertib has not reached either.

More in this section

Sources

  1. Xu Z et al. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nature Medicine 2025;31:2602–2610
  2. ClinicalTrials.gov NCT07687459 (GENESIS-IPF-3, Phase 3, China)
  3. ClinicalTrials.gov NCT05938920 (Phase 2a, China)
  4. MHRA. Launch of clinical trial reforms, 28 April 2026
  5. MHRA launches AI sandbox to accelerate medicines development and improve safety, 9 June 2026
  6. MHRA. Nerandomilast (Jascayd) approved to treat adult patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, 8 July 2026
  7. NICE. Nerandomilast for treating idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (GID-TA11552), in development
  8. Drug Discovery News. Qureight analyses of Insilico Medicine's phase IIa rentosertib data, 15 July 2025