Recent Updates
Recently added Catalysts

Drug Cocktail

Phase 1

Psoriasis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jan 29, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03718884A Study of Mirikizumab in Participants With Plaque PsoriasisPHASE1 COMPLETED 29 — — Oct 23, 2018Oct 28, 2019Jan 29, 20243 United States
NCT02993471A Study of Ixekizumab in Participants With Plaque PsoriasisPHASE1 COMPLETED 28 — — Dec 22, 2016Nov 21, 2017Mar 12, 20193 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours; post-dose
PK: Cmax of Warfarin
Period 1: Day 1: predose,1,2, 4,6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose,1,2,4,6,8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours, Day 120: 96 hours;post-dose
PK: Cmax of Dextromethorphan
Period 1: Day 1: predose, 1, 2, 4, 6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose
PK: Cmax of Omeprazole
Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose
PK: Cmax of Caffeine
Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam
Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours;post-dose

PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC \[0-∞\]) of Midazolam

PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose, 1, 2, 4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours,Day 119: 72 hours,Day 120: 96 hours;post-dose

PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Warfarin

PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose

PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Dextromethorphan

PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole
Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose

PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Omeprazole

PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose

PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Caffeine

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Midazolam)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin
Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin
Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Warfarin)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan
Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan
Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Dextromethorphan)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC\[0-48h\]) of CYP450 Substrate (Caffeine)

Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Drug CocktailEXPERIMENTALPeriod 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally
Mirikizumab + Drug CocktailEXPERIMENTALPeriod 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113) Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116.
Drug Cocktail + IxekizumabEXPERIMENTALDrug cocktail (caffeine, warfarin \[plus vitamin K\], omeprazole, dextromethorphan, and midazolam) administered orally twice in Period 2 (day 8 and day 85). Ixekizumab administered subcutaneously (SC) on multiple occasions in Period 2.
Interventions
NameTypeDescription
Drug CocktailDRUGDrug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
MirikizumabDRUGAdministered SC
IxekizumabDRUGAdministered SC
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Males and females with chronic plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy * Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical site Exclusion Cri...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Psoriasis 54 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ10PHASE3JNJ-77242113, Deucravacitinib, Ustekinumab, Guselkumab, Etanercept
Bristol-Myers Squibb CompanyBMY14PHASE3BMS-986165, Deucravacitinib, Ustekinumab, Any biologic treatment for psoriasis, Systemic psoriasis medications
AbbVie, Inc.ABBV5PHASE3Risankizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK3PHASE3TAK-279, Zasocitinib
Alumis Inc.ALMS2PHASE3Open-Label Envudeucitinib, Blinded Envudeucitinib, envudeucitinib
Eli Lilly and CompanyLLY1PHASE3Ixekizumab, Tirzepatide
Amgen Inc.AMGN2PHASE3Apremilast
Oruka Therapeutics, Inc.ORKA4PHASE2ORKA-001 Induction Dose, ORKA-002, ORKA-001
Can-Fite BioPharmaCANF1PHASE3piclidenoson
Organon & Co.OGN1PHASE3tapinarof , 1%
Vanda Pharmaceuticals Inc.VNDA1PHASE3Ponesimod
Zai Lab Ltd. Sponsored ADRZLAB1PHASE2ZL-1102 1% w/w for 16 weeks, ZL-1102 3% w/w for 16 weeks
Novartis AG Sponsored ADRNVS3 — Secukinumab
Bausch Health Companies Inc.BHC2 — Brodalumab, Matched cohort, Comparator Drug
Sage BionetworksSAGE1 — Undisclosed
Unlock Competitive Intelligence