Frequently asked questions

Is rentosertib approved?

No. Rentosertib has no marketing authorisation from any regulator anywhere in the world. It has an orphan drug designation from the US Food and Drug Administration (February 2023) and a breakthrough therapy designation from China’s Center for Drug Evaluation (May 2025), but neither of those is an approval. Both simply mean a regulator has agreed to give the programme extra attention. See about rentosertib.

Can I get rentosertib in the UK?

No. There is no UK licence, no known application to the MHRA, no early access scheme, and no expanded access or compassionate use programme anywhere. There are no UK or European trial sites and there never have been. See availability in the UK.

Can I buy it privately or online?

No legitimate supply of rentosertib exists anywhere in the world. Anything sold online under that name is unregulated. See availability in the UK.

Is it a cure for IPF?

No. Nobody has shown that rentosertib cures, stops or reverses idiopathic pulmonary fibrosis. The only published trial in people with IPF lasted 12 weeks and involved 71 people, and its main purpose was to measure side effects rather than benefit. See the GENESIS-IPF phase 2a trial.

Does it reverse ageing?

No. A September 2026 paper re-analysed blood samples from 42 of the trial participants and reported lower predicted biological age on six statistical models of blood proteins. The paper itself concedes those models cannot separate the effects of ageing from the effects of treating a disease, and the company’s chief executive has called the work a pilot that will take a decade to prove. See the “biological age” claims, explained.

What are the side effects?

In the phase 2a trial, side effects judged related to treatment rose with dose, from 5 of 17 people on placebo to 14 of 18 people on 60 mg once daily. The clearest concern is the liver: 7 of the 12 people who stopped the trial because of an adverse event did so because of liver injury or dysfunction. There was also an imbalance in sudden severe worsening of IPF, with 3 of 18 people in the 60 mg group affected against 1 of 17 on placebo. Full figures are on the safety page.

How well did it work in trials?

The authors report an increase in FVC (forced vital capacity, a measure of how much air you can breathe out) of 98.4 mL at 12 weeks in the 18 people taking 60 mg once daily, against a fall of 20.3 mL on placebo. No p-values were reported for FVC, the trial was not designed or powered to measure benefit, and the dose response was not orderly: the 30 mg once daily group did slightly worse than placebo. See the phase 2a trial.

When will it be known whether it works?

A 320-person phase 3 trial called GENESIS-IPF-3 began dosing on 10 September 2026 at 47 centres in China. It runs for 52 weeks per participant and is estimated to complete in October 2029. The trial’s lead investigator has said approval could take three to four years from the start of phase 3 under favourable conditions. See GENESIS-IPF-3.

Can I join the trial?

Not from the UK. Every phase 3 site is in China, and a separate phase 2a trial in the United States has 12 US sites. If you want to take part in IPF research, there are trials recruiting in the UK right now: see IPF trials in the UK.

Is it the first AI-discovered drug?

That depends entirely on the definition, and “AI-discovered” is not a regulatory term. Insilico says it is the first medicine where both the target and the molecule were identified using AI to reach phase 3, and that claim holds up better than most. Earlier candidates from other companies either used AI only for the molecule, or were repurposed existing drugs, and several were abandoned. No AI-discovered medicine has been approved anywhere. See the AI discovery story.

Who makes it and who owns it?

Insilico Medicine, founded in 2014 by Alex Zhavoronkov and listed on the Hong Kong stock exchange since 30 December 2025. Rentosertib is wholly owned by Insilico and has never been out-licensed, and the company is funding the phase 3 trial itself. Its large 2026 partnerships, including deals with Eli Lilly and SK Biopharmaceuticals, concern other programmes. See Insilico Medicine.

Is it being tested in the UK?

No. Rentosertib has never had a UK or European trial site at any phase. The only known UK connection is that data from the phase 2a trial was processed by a contract research organisation in Leeds. See IPF trials in the UK.

What can UK patients have now?

Two antifibrotic medicines are established on the NHS: pirfenidone and nintedanib, both approved by NICE with eligibility rules that differ between England and Scotland. A third, nerandomilast, received a UK licence from the MHRA on 8 July 2026, but NICE said in draft guidance on 27 August 2026 that it should not be routinely funded, with a final decision expected in January 2027. See IPF treatments available today.

Who runs Rentosertib UK and is it independent?

Rentosertib UK is independent and has no connection to Insilico Medicine or any other pharmaceutical company. It carries no advertising. See the about page.