Last reviewed 2026-05-29 · How we verify

SP+MS, Day Before-Only Dosing

Norgine · Phase 3 active Small molecule Under review

SP+MS, Day Before-Only Dosing is a Bowel preparation agent / Laxative combination Small molecule drug developed by Norgine. It is currently in Phase 3 development for Bowel cleansing prior to colonoscopy, Bowel cleansing prior to other colorectal procedures.

SP+MS is a bowel preparation regimen combining sodium picosulfate and magnesium sulfate administered the day before a procedure to cleanse the colon.

SP+MS, also known as a sodium picosulfate and magnesium salt solution, is a small molecule used for bowel cleansing. It is studied in a day before-only dosing regimen for conditions such as colorectal cancer, colorectal carcinoma, and colon cleansing.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	SP+MS, Day Before-Only Dosing
Sponsor	Norgine
Drug class	Bowel preparation agent / Laxative combination
Modality	Small molecule
Therapeutic area	Gastroenterology
Phase	Phase 3

Mechanism of action

Sodium picosulfate is a stimulant laxative that increases intestinal motility and fluid secretion, while magnesium sulfate acts as an osmotic laxative to draw water into the bowel lumen. Together, they produce rapid bowel evacuation to clear fecal matter and prepare the colon for endoscopic visualization. The day-before-only dosing schedule aims to simplify the preparation regimen compared to split-dose protocols.

Approved indications

Bowel cleansing prior to colonoscopy
Bowel cleansing prior to other colorectal procedures

Common side effects

Nausea
Abdominal discomfort
Vomiting
Dehydration
Electrolyte imbalance

Key clinical trials

Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults. (PHASE3)

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:

SP+MS, Day Before-Only Dosing CI brief — competitive landscape report
SP+MS, Day Before-Only Dosing updates RSS · CI watch RSS
Norgine portfolio CI

Frequently asked questions about SP+MS, Day Before-Only Dosing

What is SP+MS, Day Before-Only Dosing?

SP+MS, Day Before-Only Dosing is a Bowel preparation agent / Laxative combination drug developed by Norgine, indicated for Bowel cleansing prior to colonoscopy, Bowel cleansing prior to other colorectal procedures.

How does SP+MS, Day Before-Only Dosing work?

SP+MS is a bowel preparation regimen combining sodium picosulfate and magnesium sulfate administered the day before a procedure to cleanse the colon.

What is SP+MS, Day Before-Only Dosing used for?

SP+MS, Day Before-Only Dosing is indicated for Bowel cleansing prior to colonoscopy, Bowel cleansing prior to other colorectal procedures.

Who makes SP+MS, Day Before-Only Dosing?

SP+MS, Day Before-Only Dosing is developed by Norgine (see full Norgine pipeline at /company/norgine).

What drug class is SP+MS, Day Before-Only Dosing in?

SP+MS, Day Before-Only Dosing belongs to the Bowel preparation agent / Laxative combination class. See all Bowel preparation agent / Laxative combination drugs at /class/bowel-preparation-agent-laxative-combination.

What development phase is SP+MS, Day Before-Only Dosing in?

SP+MS, Day Before-Only Dosing is in Phase 3.

What are the side effects of SP+MS, Day Before-Only Dosing?

Common side effects of SP+MS, Day Before-Only Dosing include Nausea, Abdominal discomfort, Vomiting, Dehydration, Electrolyte imbalance.

Drug class: All Bowel preparation agent / Laxative combination drugs
Manufacturer: Norgine — full pipeline
Therapeutic area: All drugs in Gastroenterology
Indication: Drugs for Bowel cleansing prior to colonoscopy
Indication: Drugs for Bowel cleansing prior to other colorectal procedures

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