Phase II

Nephrology & Urology

pain 78#14volume 632#40

Pain rank 14 of 76, volume rank 40 of 76 by industry trials. Trials here amend about 1.2x and fail enrollment about 1.6x the map median.

What this is worth

The amendment proxy, priced. Order of magnitude, anchor cited, assumptions on the table.

Per 100 industry trials in this cell, about 47 rewrite their eligibility criteria at least once. At the industry average of $450k direct cost per amendment, with the 6+ weeks of delay each not even counted, that is at least $21M at stake per 100 trials. Across the roughly 632 industry trials here, the floor is $133M.

If amendments fell by10%$13M30%$40M50%$66M

Assumes $450k direct cost per amendment (industry average; Phase II median runs lower, Phase III higher, and delay cost is excluded), applied to the proxy rate. The proxy counts only trials with at least one eligibility change, so this understates the true exposure. How this is derived.

The signals

Industry sponsors first, since that is the commercial buyer, each figure shown against the map median. All-sponsor figures follow. A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.

Industry sponsors78pain index
Eligibility amendments
47%vs map 40%proxyn = 45sampled
Enrollment failure
22%vs map 13%n = 505concluded
Startup lag
62 dvs map 45.5 dn = 367with dates
Median duration
18.0 mon = 591completed
All sponsors82pain index
Eligibility amendments
38%proxyn = 90sampled
Enrollment failure
22%n = 977concluded
Startup lag
85 dn = 747with dates
Median duration
22.5 mon = 1,289completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (35 of 112 stopped). A keyword pass runs first; free text it could not place was sorted once by a frozen AI classification into these same categories, auditable rather than a live model. "No enrollment recorded (inferred)" is not a stated reason: it is read from a zero enrollment count, meaning the trial never enrolled anyone. "Not reported" means the sponsor left the field blank, shown rather than hidden.

Sponsor decision35 (31%)
Low accrual22 (20%)
Not reported17 (15%)
Efficacy or futility11 (10%)
Safety or tolerability9 (8%)
No enrollment recorded (inferred)inferred7 (6%)
Logistics or operations3 (3%)
Other stated reason2 (2%)
External or regulatory2 (2%)
Business or funding2 (2%)
Completed or objective met1 (1%)
Never initiated1 (1%)
n = 112terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell. Each links to its ClinicalTrials.gov record.

TrialSponsorStatusStated reason
NCT06602453Genentech, Inc.terminatedEfficacy or futility
NCT06598631Eli Lilly and CompanywithdrawnEfficacy or futility
NCT06365437ITB-Med LLCterminatedLow accrual
NCT06247241Versameb AGwithdrawnLow accrual
NCT05847920Guangdong Hengrui Pharmaceutical Co., LtdterminatedSponsor decision
NCT05810961argenxterminatedSponsor decision
NCT05740007Ironwood Pharmaceuticals, Inc.terminatedSponsor decision
NCT05599815Aldeyra Therapeutics, Inc.withdrawnLow accrual
NCT05524051Novartis PharmaceuticalsterminatedSponsor decision
NCT05475717CSPC ZhongQi Pharmaceutical Technology Co., Ltd.terminatedSponsor decision
NCT05441826Tenet MedicinesterminatedSponsor decision
NCT05162066BioCryst PharmaceuticalsterminatedSponsor decision

Nephrology & Urology at other phases