Last reviewed 2026-05-27 · How we verify

Treatment Phase Sequence 3421

Avekshan LLC · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Treatment Phase Sequence 3421 is a Small molecule drug developed by Avekshan LLC. It is currently in Phase 1 development. Also known as: Treatment 4.

Treatment Phase Sequence 3421 is not mentioned in the provided facts, but Treatment Phase Sequence 4213 is mentioned as an intervention in a study on Naltrexone and Methylphenidate Abuse. The study is a Phase 1, double-blind, crossover study evaluating the effect of Naltrexone on the abuse potential of Methylphenidate.

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	Treatment Phase Sequence 3421
Also known as	Treatment 4
Sponsor	Avekshan LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study for Naltrexone on the Abuse Potential of Methylphenidate (PHASE1)

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:

Treatment Phase Sequence 3421 CI brief — competitive landscape report
Treatment Phase Sequence 3421 updates RSS · CI watch RSS
Avekshan LLC portfolio CI

Frequently asked questions about Treatment Phase Sequence 3421

What is Treatment Phase Sequence 3421?

Treatment Phase Sequence 3421 is a Small molecule drug developed by Avekshan LLC.

Who makes Treatment Phase Sequence 3421?

Treatment Phase Sequence 3421 is developed by Avekshan LLC (see full Avekshan LLC pipeline at /company/avekshan-llc).

Is Treatment Phase Sequence 3421 also known as anything else?

Treatment Phase Sequence 3421 is also known as Treatment 4.

What development phase is Treatment Phase Sequence 3421 in?

Treatment Phase Sequence 3421 is in Phase 1.

Manufacturer: Avekshan LLC — full pipeline
Also known as: Treatment 4

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