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Nonclinical precedents · FDA + EMA

What did regulators accept for programs like yours?

Species, study lengths, skipped studies and first-dose logic for every approved product in five modalities. Every answer opens the regulator's own sentence.

109 approved products1,529 quotes verified word for wordFree to browse, no sign-up
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Five boards, 109 precedents

Monkey onlyMonkey + rodentRodent onlyOther speciesNo relevant species
18 approved

Bispecific antibodies

Median longest study 13 wk
First dose stated 3/18
14 approved

Antibody-drug conjugates

Median longest study 13 wk
First dose stated 2/14
24 approved

Oligonucleotides

Median longest study 39 wk
First dose stated 0/24
26 approved

Gene therapy

Median longest study 26 wk
First dose stated 4/26
27 approved

Cell therapy

Median longest study 26 wk
First dose stated 0/27
Field notes

Things the reviews reveal

9of 109

public reviews say how the first human dose was set. The rest left it in the confidential IND.

See the ones that did →
13of 18

approved bispecifics ran pivotal tox in: monkey only.

Species for bispecifics →
13of 14

approved ADCs ran pivotal tox in: monkey + rodent.

Species for ADCs →
1 · Pick your modality

Bispecifics, ADCs, oligonucleotides, gene therapy or cell therapy.

2 · Scan the board

Every approved product on one screen: species, study length, what was skipped, how the first dose was set.

3 · Open the source

Click any cell for the verbatim sentence, the page, and a link to the FDA or EMA document.