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Asoprisnil

Phase 3

Fibroid Uterus | Small molecule | Endocrine |Abbott Laboratories|Trials Updated: Mar 4, 2009

Asoprisnil development status

Highest phase Phase 3
Registered trials 12 across 1 sponsor since Sep 2005

Asoprisnil target and mechanism

Molecular targetPGR
Target classModulator
ModalitySmall molecule
ChEMBLCHEMBL267431

Also known as J867

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials14
Total Enrollment2,641

FDA Designations

No designations recorded

Asoprisnil clinical trials

Asoprisnil · 14 trials · 8 indications

Phase 3 6Phase 2 8
NCT00156156Study of Asoprisnil in the Treatment of Uterine Fibroids.Fibroid Uterus
COMPLETED149 Analytics
NCT00156208Safety of Treatment of Uterine Fibroids With AsoprisnilFibroid Uterus
COMPLETED166 Analytics
NCT00152256A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine FibroidsFibroid Uterus
COMPLETED239 Analytics
NCT00156195Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine FibroidsLeiomyoma
COMPLETED523 Analytics
NCT00160381A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine FibroidsLeiomyoma
COMPLETED432 Analytics
NCT00152269Treatment of Uterine Fibroids With Asoprisnil(J867)Leiomyoma
COMPLETED475 Analytics
PHASE3COMPLETED
Study of Asoprisnil in the Treatment of Uterine Fibroids.
Fibroid Uterus
NCT00156156149
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PHASE3COMPLETED
Safety of Treatment of Uterine Fibroids With Asoprisnil
Fibroid Uterus
NCT00156208166
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PHASE3COMPLETED
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Fibroid Uterus
NCT00152256239
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PHASE3COMPLETED
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
Leiomyoma
NCT00156195523
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PHASE3COMPLETED
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Leiomyoma
NCT00160381432
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PHASE3COMPLETED
Treatment of Uterine Fibroids With Asoprisnil(J867)
Leiomyoma
NCT00152269475
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Study Endpoints

Primary Endpoints

Long-term Safety.
Throughout 2 year treatment period
Long Term Safety
Throughout 18 month treatment period
Cumulative percent of subjects achieving amenorrhea.
Month 3
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Month 12
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
Month 12 or Final Visit
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.
Month 12 or Final Visit
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Final visit
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.
Months 1,3,6,9,12 and final visit
Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.
Months 3,6,9,12 and final visit
Mean change from baseline in pelvic pain as assessed by daily diary
Final month
Mean change from baseline in dysmenorrhea as assessed by daily diary
Final month
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
Months 3,6
Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
Treatment months 3 and 6 and Post-treatment months 3 and 6
Percentage of subjects that achieved amenorrhea.
Treatment months 1-6
Assessment of endometrium by endometrial biopsy
Week 12
Change from baseline in endometrial thickness as assessed by ultrasound
Week 12
Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
Mean change from baseline to Months 1, 2, 3
Percent change from baseline in uterine volume and volume of the largest fibroid.
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Day 1 to 1st post treatment menses

Secondary Endpoints

Change from baseline in the monthly bleeding score and the number of days with bleeding.
Each Month
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
Months 3, 6, 9,12,15,18, 24
Percent change from baseline in volume of the largest fibroid.
Months 12, 24
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AsoprisnilDRUGAsoprisnil 10 mg Tablet, oral Daily for up to 2 years
PlaceboDRUGPlacebo Tablet, oral Daily for 6 months
Asoprisnil/PremarinDRUG10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
Placebo and PremarinDRUGPlacebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study)...

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Frequently asked questions about Asoprisnil

What is Asoprisnil used for?

Asoprisnil was studied for the treatment of uterine fibroids (leiomyoma), endometriosis, and related gynecologic conditions including amenorrhea. It is a small molecule developed by Abbott Laboratories. All reported trials in these indications were Phase 2 studies and are now completed.

What does Asoprisnil target?

Asoprisnil targets the progesterone receptor (PGR). It is classified as a progesterone receptor modulator, meaning it binds to PGR and modulates its activity rather than simply blocking or activating it. This mechanism underlies its investigation in hormone-driven conditions such as uterine fibroids and endometriosis.

Who makes Asoprisnil?

Asoprisnil is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott sponsored the Phase 2 clinical trials evaluating the drug in uterine fibroids and endometriosis.

What phase is Asoprisnil in?

Asoprisnil is in Phase 2 development. Five Phase 2 trials have been completed, and no active trials are currently listed. The drug has not been approved by the FDA for any indication and remains investigational.

What clinical trials is Asoprisnil in?

Asoprisnil has been evaluated in five completed Phase 2 trials, including NCT00160459 in uterine fibroids, NCT00160446 and NCT00160433 in endometriosis, and NCT00160420, a long-term safety study in endometriosis. These trials enrolled a total of 1,597 participants and were randomized, double-blind, and placebo-controlled.

Other drugs targeting PGR

Dydrogesterone ABT· PHASE3 Vilaprisan BAYRY· PHASE2 levonorgestrel/ Microlut BAYRY· PHASE3 Drospirenone, Ethinylestradiol/ Yasmin BAYRY· PHASE3 Levonorgestrel Emergency Pill BAYRY· PHASE1 Gestodene/EE Patch BAYRY· PHASE3 Lonaprisan BAYRY· PHASE2 Levonorgestrel IUS BAYRY· PHASE3 Levonorgestrel IUD BAYRY· PHASE3 Onapristone CNTX· PHASE2 Mifepristone CORT· PHASE3 Progesterone DARE· PHASE1

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