Last reviewed 2026-05-18 · How we verify

18F-OP-801

Ashvattha Therapeutics, Inc. · Phase 1 active Small molecule Quality 10/100

18F-OP-801 is a Small molecule drug developed by Ashvattha Therapeutics, Inc.. It is currently in Phase 1 development. Also known as: 18F Hydroxyl Dendrimer.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	18F-OP-801
Also known as	18F Hydroxyl Dendrimer
Sponsor	Ashvattha Therapeutics, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

18F-OP-801 CI brief — competitive landscape report
18F-OP-801 updates RSS · CI watch RSS
Ashvattha Therapeutics, Inc. portfolio CI

Frequently asked questions about 18F-OP-801

What is 18F-OP-801?

18F-OP-801 is a Small molecule drug developed by Ashvattha Therapeutics, Inc..

Who makes 18F-OP-801?

18F-OP-801 is developed by Ashvattha Therapeutics, Inc. (see full Ashvattha Therapeutics, Inc. pipeline at /company/ashvattha-therapeutics-inc).

Is 18F-OP-801 also known as anything else?

18F-OP-801 is also known as 18F Hydroxyl Dendrimer.

What development phase is 18F-OP-801 in?

18F-OP-801 is in Phase 1.

Manufacturer: Ashvattha Therapeutics, Inc. — full pipeline
Also known as: 18F Hydroxyl Dendrimer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing