Last reviewed 2026-05-28 · How we verify

Aplodan (CREATINOLFOSFATE)

Phase 3 active Small molecule Quality 24/100

Aplodan (generic name: CREATINOLFOSFATE) is a creatinolfosfate drug. It is currently in Phase 3 development.

Aplodan works by increasing the levels of creatine in the body, which can help to improve muscle strength and endurance.

Aplodan, also known as creatinolfosfate, is a small molecule drug in the creatinolfosfate class. Unfortunately, there is limited information available on this compound, including its target, approved indications, and commercial status. As a result, it is difficult to provide a comprehensive summary of its use and safety profile. Further research is needed to determine the potential benefits and risks of Aplodan. Its development and current status are unclear.

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	CREATINOLFOSFATE
Drug class	creatinolfosfate
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Mechanism of action

Think of creatine like a fuel source for your muscles. When you exercise, your muscles use up energy stores, but with Aplodan, you have more fuel available to help you power through your workout. This can be especially helpful for people who engage in high-intensity activities or have muscle weakness.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Aplodan CI brief — competitive landscape report
Aplodan updates RSS · CI watch RSS

Frequently asked questions about Aplodan

What is Aplodan?

Aplodan (CREATINOLFOSFATE) is a creatinolfosfate drug.

How does Aplodan work?

Aplodan works by increasing the levels of creatine in the body, which can help to improve muscle strength and endurance.

What is the generic name of Aplodan?

CREATINOLFOSFATE is the generic (nonproprietary) name of Aplodan.

What drug class is Aplodan in?

Aplodan belongs to the creatinolfosfate class. See all creatinolfosfate drugs at /class/creatinolfosfate.

What development phase is Aplodan in?

Aplodan is in Phase 3.

Drug class: All creatinolfosfate drugs
Therapeutic area: All drugs in Other

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