Last reviewed 2026-06-02 · How we verify

Neridronate (NERIDRONIC ACID)

Phase 3 active Small molecule Quality 33/100

Neridronate (generic name: NERIDRONIC ACID) is a neridronic acid drug. It is currently in Phase 3 development for Humoral hypercalcemia of malignancy, Osteoporosis.

Neridronate works by inhibiting the enzyme Farnesyl pyrophosphate synthase, which plays a crucial role in bone resorption.

Neridronate, also known as Neridronic Acid, is a small molecule drug that targets Farnesyl pyrophosphate synthase. It is classified as a neridronic acid and is used to treat Humoral hypercalcemia of malignancy and Osteoporosis. The commercial status of Neridronate is currently unknown, and it is not clear if it is patented or available as a generic. As a pharma professional, it is essential to consider the potential safety implications of Neridronate, although specific details are not available. Further research is necessary to fully understand the pharmacological properties of Neridronate.

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	NERIDRONIC ACID
Drug class	neridronic acid
Target	Farnesyl pyrophosphate synthase
Modality	Small molecule
Therapeutic area	Bone
Phase	Phase 3

Mechanism of action

Think of bone resorption like a construction site where old buildings are torn down to make way for new ones. Farnesyl pyrophosphate synthase is like the bulldozer that helps break down the old buildings. Neridronate is like a brake that slows down the bulldozer, allowing the old buildings to remain intact and reducing the risk of bone loss.

Approved indications

Humoral hypercalcemia of malignancy
Osteoporosis

Common side effects

Headache
Myalgia
Nausea
Fatigue
Condition aggravated
Pain
Arthralgia
Back pain
Pain in extremity
Pyrexia
Bone pain

Key clinical trials

Efficacy and Safety of Intravenous Neridronic Acid in CRPS (PHASE3)
Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS) (PHASE3)
Safety of Intravenous Neridronic Acid in CRPS (PHASE3)
Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I (PHASE2,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:

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

Frequently asked questions about Neridronate

What is Neridronate?

Neridronate (NERIDRONIC ACID) is a neridronic acid drug, indicated for Humoral hypercalcemia of malignancy, Osteoporosis.

How does Neridronate work?

Neridronate works by inhibiting the enzyme Farnesyl pyrophosphate synthase, which plays a crucial role in bone resorption.

What is Neridronate used for?

Neridronate is indicated for Humoral hypercalcemia of malignancy, Osteoporosis.

What is the generic name of Neridronate?

NERIDRONIC ACID is the generic (nonproprietary) name of Neridronate.

What drug class is Neridronate in?

Neridronate belongs to the neridronic acid class. See all neridronic acid drugs at /class/neridronic-acid.

What development phase is Neridronate in?

Neridronate is in Phase 3.

What are the side effects of Neridronate?

Common side effects of Neridronate include Headache, Myalgia, Nausea, Fatigue, Condition aggravated, Pain.

What does Neridronate target?

Neridronate targets Farnesyl pyrophosphate synthase and is a neridronic acid.

Drug class: All neridronic acid drugs
Target: All drugs targeting Farnesyl pyrophosphate synthase
Therapeutic area: All drugs in Bone
Indication: Drugs for Humoral hypercalcemia of malignancy
Indication: Drugs for Osteoporosis

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