SPL026

Small Pharma Ltd · Phase 1 active Small molecule Quality 0/100

SPL026 is a Small molecule drug developed by Small Pharma Ltd. It is currently in Phase 1 development. Also known as: DMT, dimethyltryptamine, n,n-dimethytryptaimine, N,N-dimethyltryptamine.

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	SPL026
Also known as	DMT, dimethyltryptamine, n,n-dimethytryptaimine, N,N-dimethyltryptamine
Sponsor	Small 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

• SPL026 With or Without SSRIs in Participants With MDD (PHASE1)
• SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients (PHASE1, PHASE2)
• IM and IV SPL026 Drug Product in Healthy Participants (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:

• SPL026 CI brief — competitive landscape report
• SPL026 updates RSS · CI watch RSS
• Small Pharma Ltd portfolio CI

Frequently asked questions about SPL026

What is SPL026?

SPL026 is a Small molecule drug developed by Small Pharma Ltd.

Who makes SPL026?

SPL026 is developed by Small Pharma Ltd (see full Small Pharma Ltd pipeline at /company/small-pharma-ltd).

Is SPL026 also known as anything else?

SPL026 is also known as DMT, dimethyltryptamine, n,n-dimethytryptaimine, N,N-dimethyltryptamine.

What development phase is SPL026 in?

SPL026 is in Phase 1.

Related

• Manufacturer: Small Pharma Ltd — full pipeline
• Also known as: DMT, dimethyltryptamine, n,n-dimethytryptaimine, N,N-dimethyltryptamine