Drug intelligence / Profile preview

FB-101

Development stage
Phase 1
Lead developer
1ST Biotherapeutics
Modality
Small Molecules
Administration
Oral, Vaginal
01

Overview

FB-101 refers to two distinct investigational drugs in clinical development by different companies for unrelated indications: **1. FB-101 (1ST Biotherapeutics/Neuraly):** A small molecule c-Abl (Abelson tyrosine kinase) inhibitor being developed primarily for neurodegenerative diseases such as Parkinson's disease and amyotrophic lateral sclerosis (ALS). The drug is designed to block the activity of c-Abl, a protein implicated in the toxic buildup of alpha-synuclein aggregates in the brain—a hallmark of Parkinson’s pathology. Preclinical and early clinical data indicate that FB-101 crosses the blood-brain barrier and is well-tolerated in healthy volunteers[1][2][4][5]. It may also have activity against LRRK2 (Leucine-rich repeat serine/threonine-protein kinase 2), another target relevant to neurodegeneration[2]. **2. FB101 (Freya Biosciences):** A vaginal microbial immunotherapeutic developed by Freya Biosciences for women’s health indications, specifically targeting vaginal dysbiosis and potentially improving fertility outcomes such as IVF implantation success. This formulation consists of live Lactobacillus species intended to restore a healthy vaginal microbiome when administered intravaginally. Phase 1 results showed rapid resolution of dysbiosis with sustained engraftment of beneficial bacteria[6][9].

Other names
FB-101FB101FB 101
02

Targets

ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase)LRRK2 (Leucine-rich repeat serine/threonine-protein kinase 2)

Beyond the preview

Go deeper on FB-101.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on FB-101.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call