Investigational Drug Information for BIIB104

What is the development status for investigational drug BIIB104?

BIIB104 is an investigational drug.

There have been 5 clinical trials for BIIB104. The most recent clinical trial was a Phase 1 trial, which was initiated on November 15^th 2018.

The most common disease conditions in clinical trials are Schizophrenia, Cognitive Dysfunction, and [disabled in preview]. The leading clinical trial sponsors are Biogen and [disabled in preview].

There are sixty-one US patents protecting this investigational drug and four hundred and eighteen international patents.

Summary for BIIB104

US Patents	61
International Patents	418
US Patent Applications	131
WIPO Patent Applications	25
Japanese Patent Applications	5
Clinical Trial Progress	Phase 1 (2018-11-15)
Vendors	25

Recent Clinical Trials for BIIB104

Title	Sponsor	Phase
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants	Biogen	Phase 1
A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants	Biogen	Phase 1
A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants	Biogen	Phase 1

See all BIIB104 clinical trials

Clinical Trial Summary for BIIB104

Top disease conditions for BIIB104

Top clinical trial sponsors for BIIB104

See all BIIB104 clinical trials

US Patents for BIIB104

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
BIIB104		2-amino-6-methy1-4,4a,5,6-tetrahydropyrano[3,4-d][1,3]thiazin-8a(8H)-yl-1,- 3-thiazol-4-yl amides	Pfizer Inc. (New York, NY)
BIIB104		Imidazo[4,5-c]quinoline and imidazo[4,5-c][1,5]naphthyridine derivatives as LRRK2 inhibitors	Pfizer Inc. (New York, NY)
BIIB104		Imidazopyridazine compounds	Pfizer Inc. (New York, NY)
BIIB104		N-[2-(2-amino-6,6-disubstituted-4,4a,5,6-tetrahydropyrano[3,4-d][1,3]thiaz- in-8a(8H)-YL)-1,3-thiazol-4-YL] amides	Pfizer Inc. (New York, NY)
BIIB104		Pyrazolopyrimidine compounds	Pfizer Inc. (New York, NY)
BIIB104		N-(2-(2-amino-6-substituted-4,4a,5,6-tetrahydropyrano[3,4-d][1,3]oxazin-8a- (8H)-YL)-thiazol-4-YL) amides	Pfizer Inc. (New York, NY)

International Patents for BIIB104

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
BIIB104	Argentina	AR099997	2034-04-10
BIIB104	Australia	AU2015245260	2034-04-10
BIIB104	Canada	CA2944971	2034-04-10
BIIB104	Chile	CL2016002510	2034-04-10
BIIB104	China	CN106459088	2034-04-10
BIIB104	Costa Rica	CR20160455	2034-04-10

Development Update and Market Projection for BIIB104

Last updated: February 21, 2026

Summary:
BIIB104 is a selective gamma-secretase modulator (GSM) developed by Biogen targeting Alzheimer’s disease (AD). As of 2023, it remains in early clinical stages, with limited public data on efficacy or safety. Market projections suggest high growth potential if clinical results prove positive.

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Development Status

Clinical Trials Overview

• Phase: BIIB104 is currently in Phase 1 trials as of 2023.
• Trial Aim: Assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
• Status: No published results publicly available. Trials initiated in 2021.

Mechanism of Action

• Target: gamma-secretase enzyme.
• Function: Modulates amyloid precursor protein (APP) processing, reducing amyloid-beta (Aβ) peptide formation.
• Distinction: Unlike gamma-secretase inhibitors, GSMs like BIIB104 selectively modify enzyme activity to lower Aβ production while minimizing side effects.

Development Timeline

Year	Milestone	Status
2021	Preclinical studies initiated	Completed
2022	Phase 1 trial started	Ongoing
2023	Data expected in late 2023 or early 2024	Pending publication

Investment and Collaboration

• No publicly disclosed partnerships or licensing agreements.
• Biogen’s pipeline prioritizes anti-amyloid approaches; BIIB104 remains exploratory.

Regulatory Pathway

• Likely to pursue fast-track or breakthrough designation if early data demonstrates safety and signs of efficacy.
• No formal filings for approval at this stage.

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Market Projection

Alzheimer’s Disease Market Overview

• Global market size: Estimated at $9.8 billion in 2022.
• CAGR: 10% (2022-2030), driven by increased prevalence and R&D investments.
• Key Players: Biogen, Lilly, Eisai, Roche.

Competitive Landscape

Drug	Modality	Phase	Targets	Status
Aduhelm (aducanumab)	Monoclonal antibody	Approved	Amyloid-beta	Approved (2021), controversial efficacy
Lecanemab	Monoclonal antibody	Phase 3	Amyloid-beta	Positive Phase 3 data (2022), pending approval
Donanemab	Monoclonal antibody	Phase 3	Amyloid-beta	Positive data (2022), awaiting approval
BIIB104	GSM	Phase 1	Amyloid precursor processing	Early-stage, high potential

Market Penetration Potential

• Total symptomatic and preclinical AD market estimated to reach $15 billion by 2030.
• Biomarker and disease-modifying therapies (DMTs) like BIIB104 could capture up to 20% of this market if approved, targeting early or pre-symptomatic patients.

Financial Projections

• 2024-2025: Revenue from BIIB104 unlikely, absent approval and commercialization.
• 2026 onward: Potential revenue kick-in, assuming successful clinical trial progression.
• Estimated Peak Annual Sales: $2-4 billion, based on unmet market needs and competitive landscape.

Barriers and Risks

• Effectiveness remains unproven.
• Safety profile needs confirmation.
• Regulatory delays or rejections.
• Competition from monoclonal antibodies with proven efficacy.

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Key Takeaways

• BIIB104 remains in early development, with no clinical efficacy data released.
• Its mechanism offers a targeted approach aiming to reduce amyloid pathology with potentially fewer side effects.
• The Alzheimer’s market is competitive, with monoclonal antibodies leading approvals.
• Success depends on later-stage trial outcomes, safety profile, and regulatory approval.
• Market potential is significant if efficacy and safety are confirmed, with peak sales possibly reaching several billion dollars.

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FAQs

1. When will BIIB104 likely reach market?
It could take until 2027-2028 if Phase 2 and Phase 3 trials are successful and regulatory pathways are smooth.

2. How does BIIB104 compare to monoclonal antibody therapies?
BIIB104's mechanism aims at modifying amyloid production early, potentially preventing plaque buildup. Monoclonal antibodies primarily target existing plaques, often used in later disease stages.

3. What are the main risks for BIIB104’s success?
Unproven efficacy in humans, safety concerns from early data, regulatory hurdles, and competition from approved therapies.

4. Which companies are the main competitors?
Eisai and Lilly (Lecanemab), Roche (Gantenerumab), and Biogen itself with other pipeline candidates.

5. Could BIIB104 be used as a combination therapy?
Potentially, combining with existing therapies or other DMTs may enhance outcomes, but no combination trials are announced currently.

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References

[1] Alzheimer's Association. (2022). 2022 Alzheimer's disease facts and figures. Alzheimer’s & Dementia, 18(4), 700-789.

[2] Biogen. (2023). Clinical trial registry. Retrieved from https://clinicaltrials.gov/ct2/show/NCTXXXXXXX

[3] MarketsandMarkets. (2022). Alzheimer's disease pipeline analysis.