Last reviewed 2026-06-03 · How we verify

Phase 1a: OCT-980 Capsule

Octant, Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

Phase 1a: OCT-980 Capsule is a Small molecule drug developed by Octant, Inc.. It is currently in Phase 1 development.

In a Phase 1a study, Octant, Inc. investigated the safety and tolerability of the OCT-980 Capsule in healthy volunteers and participants with Autosomal Dominant Retinitis Pigmentosa (RHO-adRP). The study compared the OCT-980 Capsule to a placebo capsule.

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	Phase 1a: OCT-980 Capsule
Sponsor	Octant, Inc.
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 Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) (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:

Phase 1a: OCT-980 Capsule CI brief — competitive landscape report
Phase 1a: OCT-980 Capsule updates RSS · CI watch RSS
Octant, Inc. portfolio CI

Frequently asked questions about Phase 1a: OCT-980 Capsule

What is Phase 1a: OCT-980 Capsule?

Phase 1a: OCT-980 Capsule is a Small molecule drug developed by Octant, Inc..

Who makes Phase 1a: OCT-980 Capsule?

Phase 1a: OCT-980 Capsule is developed by Octant, Inc. (see full Octant, Inc. pipeline at /company/octant-inc).

What development phase is Phase 1a: OCT-980 Capsule in?

Phase 1a: OCT-980 Capsule is in Phase 1.

Manufacturer: Octant, Inc. — full pipeline

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