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BIIB122

Phase 2

Parkinson Disease | Small molecule | Neurology |Biogen Inc.|Last Updated: Jun 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment650

FDA Designations

No designations recorded

Clinical trial landscape

BIIB122 · 5 trials · 3 indications

Phase 2 1Phase 1 4
NCT05348785A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80Parkinson Disease
COMPLETED650 Analytics
PHASE2COMPLETED
A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80
Parkinson Disease
NCT05348785650
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Study Endpoints

Primary Endpoints

Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score Over the Treatment Period
Up to Week 144

Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (Range 0-184). A higher score indicates more severe symptoms of PD.

Maximum Observed Concentration (Cmax) of BIIB122
Up to Day 55
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122
Up to Day 55
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122
Up to Day 55
Maximum Observed Plasma Concentration (Cmax) of BIIB122
Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10; Cohort 4: At multiple time points post-dose on Day 1, Pre-dose on Days 2 to 9, Pre-dose and at multiple time points post-dose on Days 10 to 13, and at Day 20
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIIB122
Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10; Cohort 4: At multiple time points post-dose on Day 1, Pre-dose on Days 2 to 9, Pre-dose and at multiple time points post-dose on Days 10 to 13, and at Day 20
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of BIIB122
Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10; Cohort 4: At multiple time points post-dose on Day 1, Pre-dose on Days 2 to 9, Pre-dose and at multiple time points post-dose on Days 10 to 13, and at Day 20
Cohorts 1,2 and 3: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of BIIB122
Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10
Cohorts 1,2 and 3: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of BIIB122
Cohorts 1, 2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10
Cohort 4: Cmax of BIIB122 at Steady State (Cmax,ss)
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: Tmax of BIIB122 at Steady State (Tmax,ss)
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: AUC of BIIB122 Within a Dosing Interval at Steady State (AUCtau,ss)
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: Accumulation Ratio (AR) for AUC Within a Dosing Interval (AUCtau)
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: AR for Cmax
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
PK Parameter: The first time to maximum observed concentration (Tmax) for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Maximum observed plasma concentration (Cmax) occurring at Tmax for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Area under the concentration-time curve (AUC) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Time at which half the drug has been eliminated (T1/2) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Apparent systemic clearance (CL/F) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Apparent volume of distribution (Vz/F) of total reactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Profiles of [14C] BIIB122 ([14C]-DNL151) and its [14C] metabolites in plasma, urine, and feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
1 day
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
1 day
PK Parameter: Area under the concentration-time curve (AUC) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 in plasma following oral and intravenous administration
1 day
PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 has been eliminated (t1/2) in plasma after oral and intravenous administration
1 day
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
1 day
PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
1 day
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
1 day
PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval
21 days
PK Parameter: Area under the concentration-time curve of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) in plasma following oral and intravenous administration
21 days
PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) has been eliminated (t1/2) in plasma after oral and intravenous administration
21 days

Secondary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to Week 144
Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period
Up to a minimum of 48 weeks and a maximum of 144 weeks
Change From Baseline in MDS-UPDRS Parts II and III Combined Score
From Baseline up to Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIIB122 225 mgEXPERIMENTALParticipants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
BIIB122 Matching PlaceboPLACEBO_COMPARATORParticipants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
Period 1EXPERIMENTALParticipants will receive a single oral dose of BIIB122, while fasting, followed by a washout period.
Period 2EXPERIMENTALParticipants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.
Period 3EXPERIMENTALParticipants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period.
Cohort 1: Low-DoseEXPERIMENTALParticipants will receive Dose 1 of BIIB122, orally, once on Day 1.
Cohort 2: Mid-DoseEXPERIMENTALParticipants will receive Dose 2 of BIIB122, orally, once on Day 1.
Cohort 3: High-DoseEXPERIMENTALParticipants will receive Dose 3 of BIIB122, orally, once on Day 1.
Cohort 4: High-Multi-DoseEXPERIMENTALParticipants will receive Dose 3 of BIIB122, orally, once daily (QD), for 10 days.
Cohort AEXPERIMENTAL -

Interventions

NameTypeDescription
BIIB122DRUGAdministered as specified in the treatment arm
BIIB122-Matching PlaceboDRUGAdministered as specified in the treatment arm
RabeprazoleDRUGAdministered as specified in the treatment arm.
[14C] BIIB122 ([14C] DNL151)DRUGOral dose
BIIB122 (DNL151)DRUGOral doses
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites113

Key Inclusion Criteria: * Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis * Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at s...

Countries:United StatesAustriaCanadaChinaFranceGermanyIsraelItalyJapanNetherlandsPolandSpainUnited Kingdom
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Competitive Landscape -Parkinson's Disease 58 trials (matched to "Parkinson Disease")

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN2PHASE3apomorphine infusion
Prothena Corp. PlcPRTA3PHASE3Prasinezumab
Biohaven Ltd.BHVN1PHASE2BHV-8000
Denali Therapeutics Inc.DNLI1PHASE2BIIB122
AC Immune SAACIU2PHASE2ACI-7104.056 at Dose A, ACI-7104.056 at Dose B, ACI-7104.056 at Dose C
Gain Therapeutics, Inc.GANX2PHASE2Low Dose GT-02287
Eli Lilly and CompanyLLY3PHASE1LY3884961, Methylprednisolone, Sirolimus
Annovis Bio IncANVS1PHASE2buntanetap/posiphen
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
QIAGEN NVQGEN1PHASE2NEU-411
AbbVie, Inc.ABBV9 - Undisclosed
Illumina, Inc.ILMN1PHASE218F-MFBG
MeiraGTx Holdings PlcMGTX1PHASE1AAV-GAD
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Boston Scientific CorporationBSX3 - Undisclosed
AgeX Therapeutics, Inc.SER1PHASE1SER-252
Abbott LaboratoriesABT2N/AUndisclosed
Ardelyx, Inc.ARDX1PHASE2Tenapanor
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
Sage BionetworksSAGE1N/AUndisclosed
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Recent Changes (Last 90 Days)

MEDIUMJul 5, 2026NCT05348785TRIAL_REMOVED: changed
MEDIUMJul 5, 2026NCT05348785TRIAL_REMOVED: changed
MEDIUMJul 5, 2026NCT05348785TRIAL_REMOVED: changed

Frequently asked questions about BIIB122

What is BIIB122 used for in Parkinson Disease?

BIIB122 is an investigational small molecule being studied for its potential to slow the worsening of early-stage Parkinson's disease in adults between the ages of 30 and 80. It is not approved and remains in clinical development.

Who makes BIIB122?

BIIB122 is being developed by Biogen Inc., whose stock trades under the ticker BIIB. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and effects in healthy volunteers and in patients with Parkinson's disease.

What phase is BIIB122 in?

BIIB122 is in Phase 1 and Phase 2 clinical development. The Phase 1 trials have been completed, and a Phase 2 study in early-stage Parkinson's disease has also been completed. The drug is investigational and not yet approved.

What clinical trials is BIIB122 in?

BIIB122 has been studied in several completed trials, including NCT05005338 and NCT05229562 in healthy volunteers, NCT05348785 in Parkinson's disease, and NCT06264440 for drug-drug interactions. All trials listed are completed.

Is BIIB122 the same as DNL151?

Yes, BIIB122 is also known as DNL151. One clinical trial, NCT05005338, is titled 'A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects,' confirming that both names refer to the same drug.

What does BIIB122 target?

BIIB122 is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The trials focus on its safety, tolerability, and pharmacokinetics in healthy volunteers and its efficacy in Parkinson's disease.