Last reviewed 2026-05-25 · How we verify

Radiolabelled T4 Tablet

BDD Pharma Ltd · Phase 1 active Small molecule ✓ Verified May 2026

Radiolabelled T4 Tablet is a Small molecule drug developed by BDD Pharma Ltd. It is currently in Phase 1 development. Also known as: Delayed release diclofenac potassium tablet.

Radiolabelled T4 Tablet is a small molecule used in a study to investigate its behavior in the body. It has been studied as a potential treatment for pain, although the exact mechanism of action is not specified.

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	Radiolabelled T4 Tablet
Also known as	Delayed release diclofenac potassium tablet
Sponsor	BDD Pharma Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Investigate Delayed-release Tablets (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:

Radiolabelled T4 Tablet CI brief — competitive landscape report
Radiolabelled T4 Tablet updates RSS · CI watch RSS
BDD Pharma Ltd portfolio CI

Frequently asked questions about Radiolabelled T4 Tablet

What is Radiolabelled T4 Tablet?

Radiolabelled T4 Tablet is a Small molecule drug developed by BDD Pharma Ltd.

Who makes Radiolabelled T4 Tablet?

Radiolabelled T4 Tablet is developed by BDD Pharma Ltd (see full BDD Pharma Ltd pipeline at /company/bdd-pharma-ltd).

Is Radiolabelled T4 Tablet also known as anything else?

Radiolabelled T4 Tablet is also known as Delayed release diclofenac potassium tablet.

What development phase is Radiolabelled T4 Tablet in?

Radiolabelled T4 Tablet is in Phase 1.

Manufacturer: BDD Pharma Ltd — full pipeline
Also known as: Delayed release diclofenac potassium tablet

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