LABELS · 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43

Lifyorli

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-03-26
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. ( 1 , 14 )

Full extracted label fields

application numbers

NDA220641

boxed warning exact

brand names

Lifyorli

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6fcebfb5-19d6-4f63-b852-999d68a13729

generic names

RELACORILANT

41bf3142-d0f6-4f0c-b6da-5abe8ad3db43

indications and usage exact

1 INDICATIONS AND USAGE LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. ( 1 , 14 )

indications and usage tables exact

is original packager

true

manufacturer names

Corcept Therapeutics Incorporated

matched search terms

cancer

package ndcs

76346-425-11
76346-425-01
76346-025-01
76346-100-01
76346-525-33
76346-525-03
76346-525-09
76346-450-11
76346-450-01
76346-550-33
76346-550-03
76346-550-09

product ndcs

76346-425
76346-525
76346-450
76346-550

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2739542
2739548
2739550
2739552
2739553
2739554
2739555
2739556
2739557
2739558
2739559
2739560

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 200
total: 830

terms

https://open.fda.gov/terms/

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2241bf3142-d0f6-4f0c-b6da-5abe8ad3db43%22

spl effective date

2026-03-26

spl effective time

20260326

spl set id

6fcebfb5-19d6-4f63-b852-999d68a13729

spl version

substance names

uniis

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA220641
payload
all indexed label documents
Appl No
220641
Application Docs Date
2026-05-21 00:00:00
Application Docs ID
85997
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220641s000lbl.pdf
Submission No
1
Submission Type
ORIG
all submission records
Appl No
220641
Review Priority
STANDARD
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2026-03-25 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA220641
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220641
has approved submission record
true
latest approved submission date
2026-03-25
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
220641
Application Docs Date
2026-05-21 00:00:00
Application Docs ID
85997
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220641s000lbl.pdf
Submission No
1
Submission Type
ORIG
official application record
Appl No
220641
Appl Public Notes
Appl Type
NDA
Sponsor Name
CORCEPT THERAP
openfda application present
true
products
Active Ingredient
RELACORILANT
Appl No
220641
Drug Name
LIFYORLI (COPACKAGED)
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
100MG;25MG
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA220641

brand names

Lifyorli

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 538
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary perito
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
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source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
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current approval status

not_reconciled

duplicate text group

dup-2d488fcb26269fd8e888

extraction review status

automated_candidate_pending_source_review

generic names

RELACORILANT

ind-span-f136b5bc4572718ac223

label id

41bf3142-d0f6-4f0c-b6da-5abe8ad3db43

positive predicate support span

end: 45
end exclusive: true
exact text: is indicated
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 33

qualifier mentions

context exact
ted in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube,
kind
age
polarity
not_inferred
span
end
108
end exclusive
true
exact text
adults
label id
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offset unit
unicode_code_points
source array index
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source field
indications_and_usage_exact
source text sha256
fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start
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context exact
elial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] .
kind
prior_therapy_or_line
polarity
not_inferred
span
end
337
end exclusive
true
exact text
who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )]
label id
41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit
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source field
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source text sha256
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start
198
context exact
1 INDICATIONS AND USAGE LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which
kind
regimen
polarity
not_inferred
span
end
225
end exclusive
true
exact text
in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to th
label id
41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit
unicode_code_points
source array index
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source field
indications_and_usage_exact
source text sha256
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start
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regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 338
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] .
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2241bf3142-d0f6-4f0c-b6da-5abe8ad3db43%22

spl effective date

2026-03-26

spl set id

6fcebfb5-19d6-4f63-b852-999d68a13729

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · positive indication candidate

application numbers

NDA220641

brand names

Lifyorli

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 670
end exclusive: true
exact text: lial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. ( 1 , 14 )
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 139

current approval status

not_reconciled

duplicate text group

dup-db2ead0596769b348cbb

extraction review status

automated_candidate_pending_source_review

generic names

RELACORILANT

ind-span-400310da1ff839ed7092

label id

41bf3142-d0f6-4f0c-b6da-5abe8ad3db43

positive predicate support span

end: 397
end exclusive: true
exact text: is a glucocorticoid receptor antagonist indicated
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 348

qualifier mentions

context exact
ted in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube,
kind
age
polarity
not_inferred
span
end
460
end exclusive
true
exact text
adults
label id
41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start
454
context exact
elial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
658
end exclusive
true
exact text
who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab
label id
41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit
unicode_code_points
source array index
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source field
indications_and_usage_exact
source text sha256
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start
550
context exact
LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which
kind
regimen
polarity
not_inferred
span
end
577
end exclusive
true
exact text
in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to th
label id
41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit
unicode_code_points
source array index
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source field
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source text sha256
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start
398

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 659
end exclusive: true
exact text: LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 339

source url

https://api.fda.gov/drug/label.json?search=id%3A%2241bf3142-d0f6-4f0c-b6da-5abe8ad3db43%22

spl effective date

2026-03-26

spl set id

6fcebfb5-19d6-4f63-b852-999d68a13729

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 3 · unclassified context

application numbers

NDA220641

brand names

Lifyorli

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 670
end exclusive: true
exact text: with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. ( 1 , 14 )
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 460

current approval status

not_reconciled

duplicate text group

dup-1f42ee1bf3c3013e3f83

extraction review status

automated_candidate_pending_source_review

generic names

RELACORILANT

ind-span-183507382fdbe6c56397

label id

41bf3142-d0f6-4f0c-b6da-5abe8ad3db43

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

end: 670
end exclusive: true
exact text: ( 1 , 14 )
label id: 41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fab7d83019b51f0b036300f93a434ac3356a5efafbf594f035e04f157c635658
start: 660

source url

https://api.fda.gov/drug/label.json?search=id%3A%2241bf3142-d0f6-4f0c-b6da-5abe8ad3db43%22

spl effective date

2026-03-26

spl set id

6fcebfb5-19d6-4f63-b852-999d68a13729

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice