SHINKEI Therapeutics

What SHINKEI Therapeutics does

SHINKEI Therapeutics is a privately held, clinical-stage pharmaceutical company headquartered at 303A College Road East, Princeton, NJ. The company applies the FDA 505(b)(2) regulatory pathway to develop novel formulations of existing pharmaceutical products repurposed for central nervous system (CNS) indications that have limited or no approved therapies. It was co-founded by Suresh Borsadia (CEO/Director) and GP Singh (Chairman), industry veterans with prior leadership roles at Jubilant Pharma, Sun Pharmaceuticals, Caraco Pharma, and other large pharmaceutical organizations. Operating with a lean team of 1-10 employees supported by advisors and consultants, the company runs a virtual model that outsources clinical operations to specialized partners.

The pipeline comprises four drug candidates: MR-301, a novel IV formulation of an NMDA-antagonist for severe traumatic brain injury and disorders of consciousness; MR-101, a VMAT2 inhibitor being developed for hyperkinetic movement disorders in Huntington's Disease; MR-201, a novel NMDA-antagonist formulation for pseudobulbar affect; and MR-601, a Cannabidiol combination platform designed to improve CBD bioavailability and reduce hepatoxicity at lower doses. MR-301 has completed a Phase 2 trial (SHINKEITBI, in collaboration with Duke Clinical Research Institute), MR-101 received FDA IND clearance for Phase 1 in healthy volunteers, and MR-201 is at IND stage. Lead candidates target indications where existing treatments have significant limitations, including black-box warnings, QTc prolongation, and dose-limiting toxicity.

The company is pre-revenue and does not commercialize products directly. Its stated go-to-market is out-licensing, partnerships, and strategic alliances — explicit solicitation of business development relationships is a primary stated activity. To date, no licensing transaction, funding round, or institutional investor has been disclosed in the available source material. Commercial reach will depend on securing a development and commercialization partner for each asset.

Name

SHINKEI Therapeutics

Legal name

SHINKEI Therapeutics

Website

https://shinkeitherapeutics.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

SHINKEI Therapeutics is a privately held, clinical-stage pharmaceutical company that uses the FDA 505(b)(2) pathway to develop novel formulations of existing drugs for CNS disorders with limited approved therapies. Its pipeline targets severe TBI, Huntington's disease, pseudobulbar affect, and CBD-responsive conditions, with monetization via out-licensing and partnerships.

Ownership category

akta.pro rank

Product category

CNS Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF), Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA), Neurogenetics & Rare Neurologic Diseases (HLAKAIAO)

Keywords

• Clinical stage pharmaceuticals
• CNS disorder therapies
• Drug repurposing development
• Neurological drug pipeline
• 505(b)(2) regulatory pathway

Headquarters

HQ city

Princeton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical stage company. Future revenue expected from commercialization of drug candidates through out-licensing, partnerships, or direct sales upon FDA approval. Company focuses on repurposing existing pharmaceutical products for faster development and approval via 505(b)(2) pathway.
2. Out-licensing and Strategic Partnerships: Company is actively seeking out-licensing, partnerships and strategic alliances to bring products under development to market globally and to enhance existing development portfolio.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

SHINKEI Therapeutics is a clinical-stage pharmaceutical company developing novel drug formulations for central nervous system (CNS) disorders using the 505(b)(2) regulatory pathway to repurpose existing pharmaceutical products. Its pipeline includes MR-101 (VMAT2 inhibitor for Huntington's Disease), MR-201 (NMDA-antagonist for Pseudobulbar Affect), MR-301 (IV NMDA-antagonist for Severe Traumatic Brain Injury), and MR-601 (Cannabidiol Combination Platform). The company is pre-revenue and currently seeking out-licensing, partnership, and strategic alliance deals to commercialize its pipeline globally.

Product overview

SHINKEI Therapeutics is a clinical-stage pharmaceutical company using the 505(b)(2) regulatory strategy to repurpose existing pharmaceutical products for CNS disorders. The company has a diversified pipeline of four drug candidates: MR-101 (VMAT2 inhibitor for Huntington's Disease), MR-201 (novel NMDA-antagonist formulation for Pseudobulbar Affect), MR-301 (IV Solution for Severe Traumatic Brain Injury), and MR-601 (Cannabidiol Combination Platform). These products leverage reformulation and new delivery approaches to address unmet clinical needs in movement disorders, consciousness disorders, and neurological conditions.

Differentiator

Problem solved

Functional benefit

Products and services

• MR-101 A VMAT2 inhibitor being developed for Huntington's Disease, targeting hyperkinetic movement disorders (chorea). MR-101 is positioned as offering an improved side-effect profile compared to existing FDA-approved therapies such as Xenazine (tetrabenazine) and Austedo (deutetrabenazine). FDA IND clearance was received in March 2026 to begin Phase 1 in healthy volunteers.
• MR-201 A novel formulation of an NMDA-antagonist being developed for Pseudobulbar Affect (PBA), a condition characterized by uncontrollable crying and/or laughing episodes secondary to neurologic disorders or brain injuries (TBI, Alzheimer's, stroke, MS, ALS, Parkinson's). Targeted to address limitations of the only FDA-approved drug NUEDEXTA (drug-drug interaction and QTc prolongation from quinidine sulfate). IND was submitted to FDA in August 2019.
• MR-301 A novel intravenous (IV) formulation of an NMDA-antagonist being developed for Severe Traumatic Brain Injury (sTBI) resulting in disorders of consciousness (coma, vegetative state, minimally conscious state). MR-301 addresses an unmet need as there is no approved drug therapy for these conditions, with only 24% of VS traumatic patients and 50% of MCS patients improving spontaneously at one-year follow-up. IND accepted by FDA in August 2019; Phase 2 successfully completed March 2026.
• MR-601 A unique combination technology platform for administering Cannabidiol (CBD) at lower dosage levels for CNS disorders (anticonvulsive, sedative, hypnotic, antipsychotic, anti-inflammatory, neuroprotective indications). Improves CBD bioavailability over standard oral administration (~6%) and potentially reduces dose-related hepatoxicity (elevations of ALT/AST) associated with high-dose oral CBD.

Quantifiable outcome

• Phase 2 SHINKEITBI trial successfully completed evaluating MR-301 IV Solution in patients with severe traumatic brain injury
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Duke Clinical Research InstitutecoreStrategic or Co-development PartnerDuke Clinical Research Institute served as the collaborative partner for the Phase 2 SHINKEITBI trial evaluating MR-301 IV Solution in patients with severe traumatic brain injury. The trial was conducted across multiple U.S. sites, demonstrating strategic alignment with a leading academic research institution for clinical development.
• FDAcoreOthersFDA has cleared SHINKEI's IND application for MR-101 and accepted the IND filing for MR-301. The company is preparing for an End-of-Phase 2 meeting with FDA to align on Phase 3 pivotal study design for MR-301. Regulatory engagement is fundamental to the company's 505(b)(2) development pathway.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Teva Pharmaceutical Industries: Teva markets Austedo, a VMAT2 inhibitor approved for Huntington's disease chorea - directly competing with SHINKEI's MR-101 in the same mechanism class for the same indication.
• Lundbeck: Established CNS-focused pharmaceutical company with broad neurology portfolio - serves as a potential partner/acquirer and operates in the same CNS specialty space as SHINKEI.
• H. Lundbeck / Otsuka (Lundbeck-Otsuka partnership): Partnerships between CNS incumbents to develop and commercialize CNS therapies - represents the type of large-pharma alliance SHINKEI is actively seeking via its out-licensing model.

Direct peers

• Sage Therapeutics: Clinical-stage CNS specialty pharmaceutical company developing novel therapeutics for neurological and psychiatric disorders, with a similar focus on differentiated CNS mechanisms and unmet needs.
• Acadia Pharmaceuticals: CNS-focused specialty pharma that developed NUEDEXTA for PBA (SHINKEI's MR-201 indication) and other CNS therapies - a direct competitor in the PBA space and a comparable CNS commercial-stage model.
• Aquestive Therapeutics: Specialty pharma leveraging proprietary drug delivery and formulation technologies to develop CNS therapies - similar reformulation/repurposing approach to SHINKEI's 505(b)(2) strategy.
• Intra-Cellular Therapies: CNS specialty pharmaceutical company developing novel treatments for neurological and psychiatric disorders, comparable in focus on CNS indications and clinical-stage development model.
• Biohaven Pharmaceuticals: Clinical-stage CNS biopharma developing therapies for neurological diseases including rare neurological disorders - similar pipeline focus and stage of development as SHINKEI.
• Auspex Pharmaceuticals (acquired by Teva): Developed deuterated VMAT2 inhibitors (Austedo) for Huntington's disease - established the competitive benchmark that SHINKEI's MR-101 VMAT2 inhibitor must beat on safety profile.
• NeuroBo Therapeutics: Clinical-stage biotech focused on neurodegenerative diseases including ALS and diabetic neuropathy - comparable in scale, stage and CNS therapeutic focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/shinkei-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SHINKEI Therapeutics