Phase II

Immunology & Inflammation

pain 78#14volume 1,971#10

Pain rank 14 of 76, volume rank 10 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 50 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 $23M at stake per 100 trials. Across the roughly 1,971 industry trials here, the floor is $444M.

If amendments fell by10%$44M30%$133M50%$222M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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
50%vs map 40%proxyn = 226sampled
Enrollment failure
21%vs map 13%n = 1,601concluded
Startup lag
59 dvs map 45.5 dn = 1,165with dates
Median duration
18.1 mon = 1,895completed
All sponsors85pain index
Eligibility amendments
47%proxyn = 318sampled
Enrollment failure
23%n = 2,520concluded
Startup lag
74 dn = 1,975with dates
Median duration
22.0 mon = 3,249completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (99 of 340 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 decision99 (29%)
Low accrual63 (19%)
Efficacy or futility54 (16%)
Safety or tolerability45 (13%)
Not reported32 (9%)
No enrollment recorded (inferred)inferred9 (3%)
Logistics or operations7 (2%)
Business or funding7 (2%)
Feasibility or operational failure4 (1%)
Never initiated4 (1%)
Completed or objective met4 (1%)
External or regulatory4 (1%)
Superseded by another study3 (1%)
Other stated reason2 (1%)
Change in standard of care2 (1%)
Technical or device issue1 (0%)
n = 340terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07100938BeiGeneterminatedSponsor decision
NCT06935474AbelZeta Inc.withdrawnSponsor decision
NCT06859294Eli Lilly and CompanyterminatedEfficacy or futility
NCT06646016Therakos LLCwithdrawnLow accrual
NCT06623240Hope Biosciences Research FoundationwithdrawnLow accrual
NCT06570434Tenet MedicineswithdrawnNever initiated
NCT06495307Lubris Bio Pty LtdterminatedEfficacy or futility
NCT06312020AmgenterminatedEfficacy or futility
NCT06161116Merck Sharp & Dohme LLCterminatedSponsor decision
NCT06153095Lyell Immunopharma, Inc.withdrawnSponsor decision
NCT06137183Genentech, Inc.terminatedEfficacy or futility
NCT06095986Galmed Pharmaceuticals LtdwithdrawnFeasibility or operational failure

Immunology & Inflammation at other phases