Non-Muscle Invasive Bladder Cancer Drug Pipeline Review

How many non-muscle invasive bladder cancer drugs are in each phase of development?

Douglas Insights counts 18 non-muscle invasive bladder cancer candidates in Phase III, 40% of the 45 assets in development; Phase II holds 6 and Phase I holds 21.

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each non-muscle invasive bladder cancer asset appears in exactly one row. The 119 trials still recruiting or running carry 61% of the 195 registered trials in scope.

Which approved non-muscle invasive bladder cancer medicines are still in trials?

1 medicines already on the market are still being tested in non-muscle invasive bladder cancer Phase IV trials; BCG has the most, with 26 registered trials.

Post-approval non-muscle invasive bladder cancer trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.

How many non-muscle invasive bladder cancer trials are recruiting patients now?

62 non-muscle invasive bladder cancer trials are recruiting patients and 21 more have not started recruiting yet, out of 195 interventional trials in scope; together they make up 43% of the trial base.

Terminated, suspended and withdrawn non-muscle invasive bladder cancer trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the non-muscle invasive bladder cancer pipeline?

Merck Sharp & Dohme LLC leads the non-muscle invasive bladder cancer pipeline with 4 candidates; the top 5 sponsors hold 36% of the 45 assets, and 32 sponsors run at least one.

Industry sponsors lead 95 of the 195 non-muscle invasive bladder cancer trials (49%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the non-muscle invasive bladder cancer pipeline?

Mechanism and drug-type classification for the 45 non-muscle invasive bladder cancer candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What non-muscle invasive bladder cancer trial readouts are coming next?

6 non-muscle invasive bladder cancer candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many non-muscle invasive bladder cancer readouts fall in each quarter?

13 non-muscle invasive bladder cancer candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 4, due in Q4 2026.

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most non-muscle invasive bladder cancer trials?

United States hosts the most non-muscle invasive bladder cancer trials, with sites in 94 of the 195 studies (48%); trials in scope run in 56 countries in all.

A multinational non-muscle invasive bladder cancer trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are non-muscle invasive bladder cancer drugs being tested?

94 of the 195 non-muscle invasive bladder cancer trials (48%) have a site in the United States, 52 (27%) in Europe and 53 (27%) in China; 32 of the 45 candidates in development are tested in the US.

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational non-muscle invasive bladder cancer trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the non-muscle invasive bladder cancer pipeline since the last update?

This is the first edition of the non-muscle invasive bladder cancer pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the non-muscle invasive bladder cancer pipeline?

Douglas Insights read 195 interventional trials registered on ClinicalTrials.gov for the conditions "Non-Muscle Invasive Bladder Neoplasms", "non-muscle invasive bladder cancer" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 45 unique candidates.

1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

Frequently asked questions about the non-muscle invasive bladder cancer pipeline

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

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